Previewing biopharma trends ahead of #BIO22; Looking back at #ASCO22; Smooth flight for bluebird?; and more
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
With ASCO behind us and BIO just ahead, we’re feeling the heat of the biotech summer. Many of my colleagues will be in San Diego next week. Safe travels to everyone making the trip there.
Endpoints News will be hosting our first in-person events at BIO in two years, and we have a full slate of panels lined up to discuss biopharma at the crossroads. Setting the stage, Endpoints founder John Carroll chatted with BIO chair Paul Hastings, polled the E100 group of biotech CEOs for their sentiments as well as views on hot button issues, and asked DealForma chief Chris Dokomajilar to crunch the numbers a little bit early on H1 for a look at the trends in play. The special preview also features a look into M&A for the second half of the year, according to seasoned players, and perspectives from real estate developers. Here’s the full lineup with more details.
#ASCO22: View from the ground
Over the past weekend, tens of thousands of physicians, clinical trial investigators, academics, R&D scientists and biopharma leaders descended upon Chicago for the first in-person ASCO meeting since the pandemic onset. And as Kyle LaHucik observed on the sidelines of the conference, even as a suite of prominent drugs swept the headlines with data updates, mingling face-to-face stole the spotlight as execs reunited with “50,000 of (their) closest friends.” Check out our full coverage here.
Smooth flight for bluebird?
Ahead of what may be make-or-break meetings for bluebird bio, the FDA released briefing documents on two of its gene therapies signaling a likely green light for one to treat a rare blood disorder and questions for the other — an experimental treatment for cerebral adrenoleukodystrophy — due to uncertainty in both benefit and risk. Surprisingly, though, the adcomm gave a big thumbs up to both the CALD and beta-thalassemia therapies despite those concerns.
ARCH’s manufacturing play racks up cash, partners
Resilience, the CDMO with ambitions to become the Foxconn of biomanufacturing, had quite the week. It got a boost in the form of a $625 million Series D, which will be used to continue investing in its infrastructure through more deals, potential acquisitions and R&D expansion so that it can do it all — and be ready for anything. Then it cracked open two partnerships, first with the University of Texas MD Anderson Cancer Center then with the Parker Institute for Cancer Immunotherapy, around cell and gene therapies for cancer.
GV plucks up Novartis vet for latest entrepreneur-in-residence
David Schenkein has added a new member to GV’s still quite exclusive club of biotech CEOs-in-waiting. And this time the Google Ventures player is turning to someone he’d worked with for years at Agios, the company he built from a white sheet of paper. Schenkein recruited Kevin Marks out of NIBR, where he’s been working as head of the oncology discovery group, a move that he says represents the “growth mode” at GV life sciences. While he’s not rushing to join a startup, Marks noted drug resistance is a key arena he’s focused on.
- Following back-to-back Phase III TIGIT flops, Roche spelled out the data on the first failed trial, dubbed SKYSCRAPER-02. Compared to an average overall survival of 12.9 months with only Tecentriq and chemotherapy, the addition of tiragolumab failed to move the needle at all, with an overall survival of 13.1 months — an admittedly disappointing result.
- In the latest in a series of big clinical setbacks, Pfizer detailed how its closely watched PALOMA-2 Phase III study of Ibrance combined with the chemo hormone therapy Femara (letrozole) failed to significantly move the dial on survival for first-line cases of metastatic breast cancer compared to Femara alone, with a marginal hazard ratio of 0.956. The pharma giant was left defending the CDK4/6 franchise.
- Mirati Therapeutics is pulling out all the stops to beef up its case for adagrasib as it plays catch-up to Amgen’s Lumakras. In 19 evaluable patients with non-small cell lung cancer who have active and untreated CNS metastases, the biotech said its drug led to six objective intracranial responses, a first in CNS-specific activity.
- Breast cancer is often categorized by well-defined subgroups, but with their latest Enhertu data, AstraZeneca and Daiichi Sankyo believe they may just cement a new one: HER2-low. Among a group of patients who previously would’ve been considered HER2-negative, Enhertu beat out chemotherapy in staving off the cancer and extending overall survival.
- Months after drawing ire and inviting skepticism from analysts for releasing an upbeat Q&A without any hard data for its latest Trodelvy trial, Gilead released the full data at ASCO, showing that the antibody-drug conjugate slightly outdid standard care in a Phase III study involving patients with HR+/HER2- metastatic breast cancer.
- Legend and J&J’s Janssen said Carvykti, the second FDA-approved BCMA CAR-T, has shown it can stay effective at almost 28 months of median follow-up. The therapy, which first took ASCO by surprise five years ago, saw its overall response rate remaining consistent at 98% among the 97 patients treated, with 70% of the patients still alive.
- Here’s another slate of upbeat data coming from a low-profile Chinese biotech: Shanghai-based OriCell, a private player, highlighted promising Phase I results for its personalized GPRC5D-directed CAR-T OriCAR-017. Directed at a small group of treatment-resistant patients suffering from multiple myeloma, the biotech reported a 100% overall response rate with 60% stringent CRs. The trial also recruited patients who failed a BCMA-directed CAR-T.
- Looking to build on its breakout Covid success and put together an oncology franchise, BioNTech is back with more data on its individualized mRNA cancer jab known as autogene cevumeran in the most common form of pancreatic cancer. Specifically, it shared more about a single-site Phase I study among a subset of patients with poor prognosis.
- Adicet gave a detailed breakdown of its buoyant early data for its off-the-shelf gamma delta T cell play, revealing that at the data cutoff, six of the eight patients enrolled recorded a complete response. That’s likely to sharpen the focus on the gamma delta crowd — which is hoping to see enhanced efficacy — but durability remains to be seen.
- Mismatch repair-deficient, a rare biomarker, was the spotlight of a small Phase I study where every single patient treated with GSK’s PD-1, Jemperli (dostarlimab), saw their rectal cancer completely disappear. None of them needed chemotherapy, radiation, or surgery — the combination that makes up the standard of care for this disease.
- As it dodges a takeover bid, Zymeworks wants to follow Daiichi Sankyo’s footsteps in finding a Big Pharma partner to turn its HER2 bispecific, zanidatamab, into a worldwide drug. And it said it has the data to support it, reporting 1 complete response and 18 partial responses in a small study — translating to a confirmed ORR of 90.5%.
- Merus wants to tackle a rare genomic fusion in oncology that impacts about 5,000 new patients in the US each year, and the biotech thinks its interim efficacy data — sporting a 34% overall response rate — can lead its bispecific zenocutuzumab to become the first approved med for those patients. Meanwhile, chief competitor Elevation Oncology disclosed its own data update.
- CG Oncology built on some head-turning AACR data on a combination of its oncolytic virus with Merck’s Keytruda for bladder cancer; EQRx conceded that, even though the PD-L1 inhibitor it licensed from CStone delivered positive Phase III, it plans to file for approval outside of US first. Here’s the best of the rest from the ASCO weekend.
- Add Canada to the list of countries where Biogen’s controversial Alzheimer’s drug Aduhelm isn’t wanted by health officials. The biotech is pulling aducanumab’s new drug submission in Canada after the country’s health agency indicated that “the data provided would not be sufficient to support a marketing authorization.”
- Bristol Myers Squibb laid out some big plans over the last couple of years around potential label expansions for its Celgene-acquired anemia drug Reblozyl. But one of those will no longer be in the cards as BMS pulled the plug on an anemia program as regulators call into question the drug’s risk-benefit profile in a rare blood disorder.
- Novartis is the latest company to fall victim to a cyberattack. Specialized IT website Bleeping Computer first reported that the Swiss giant got hacked late last week, after hacking group Industrial Spy offered up data on its “extortion marketplace” that was apparently stolen from Novartis labs. The company said little other than that it’s aware of the matter and no sensitive data have been compromised.
- Amid increased concerns about the lack of clinical trial diversity, new research suggests that many Black patients aren’t made aware of trials in the first place. Of 102 patients who self-identified as Black in a recent Metastatic Breast Cancer Alliance survey, 40% said that no one on their care team had discussed clinical trials, even though more than 90% said they would be interested in learning about them.
- Having racked up approvals in more than 100 countries, GSK is bringing one of its widely-licensed vaccines to the US, giving pediatricians a new option for a common childhood shot for the first time in more than 50 years. The FDA approved GSK’s measles, mumps and rubella vaccine for individuals 12 months and older, which is branded as Priorix.
- More than four years after Roche bought Ignyta, acquiring a drug — entrectinib — that scored FDA approval about 18 months later, Roche now has a companion diagnostic to pair with that drug and expanded treatment options. The agency approved a companion diagnostic from Foundation Medicine for entrectinib, which is currently being marketed as Rozlytrek.
- A letter authored by a trio of Harvard researchers — including medical professors Ben Rome and Aaron Kesselheim — sought to add clarity to how the launch price for newly-FDA-approved drugs has been steadily increasing. Between 2008 and 2021, they wrote, the launch prices for prescription drugs skyrocketed almost 90x.
- As it rounds out its first decade as an independent company on Wall Street, AbbVie joined some of its pharma brethren in laying out an Environment, Social & Governance strategy. Amid a big sustainability push in the industry, AbbVie has been able to reduce its carbon emissions by 25% since 2015. By 2035, the company hopes to reach 50% — alongside other goals.
- Senator Raphael Warnock, Democrat of Georgia, urged Senate Majority Leader Chuck Schumer to follow through on his promise to bring to vote a bill that would cap monthly insulin costs at $35 for those with insurance. In a letter, he said “Georgians are hurting” and that he’s deeply disappointed.
- GSK announced that its adult RSV vaccine cleared a Phase III trial offering “exceptional protection” to 25,000 enrollees over the age of 60, setting up a planned rollout with regulators. But while GSK cheered this as a clear success, and a landmark first, it’s keeping the key figure on efficacy in preventing severe infections under wraps, for now, leaving the next big question of how this will look to regulators and industry rivals still unanswered.
- Disappointing Phase II/III results for Praxis’ lead depression drug sent the biotech’s shares on a nosedive, forcing a substantial pipeline reorganization and layoffs. A candidate that once inspired high hopes, the GABA positive allosteric modulator has had a bumpy road. It missed the primary endpoint as well as all of its secondary endpoints.
- Innovent Biologics burst onto the obesity scene, crashing the big rivalry between Eli Lilly and Novo Nordisk, with Phase II data showing its GLP-1 receptor/glucagon receptor dual agonist reduced patients’ body weights by more than 12% at the highest dose compared to placebo. The trial was conducted in China.
- A California biotech familiar with speed bumps ran into another early Wednesday as it tries to push its only approved drug into another indication. According to Rigel Pharmaceuticals, a surprising placebo response spurred the Phase III failure for its bleeding disorder drug fostamatinib. But it’s no stranger to headwinds.
- Blueprint is forging ahead on its slow crawl to broaden its market for Ayvakit. For the second part of a Phase II trial in the non-advanced form of systemic mastocytosis, the biotech is swapping out the primary endpoint at the FDA’s recommendation so that it can look at a broader group of patients
- Alnylam is showing off some new efficacy data on a drug at the heart of its $1 billion-plus Regeneron collaboration cemented three years ago. The positive news centers on a Phase II descriptive trial for cemdisiran, an RNAi drug targeting the C5 component of the pathway that the partners are working on in the kidney disease known as IgAN.
- As it looks to bring lebrikizumab to market and challenge Dupixent, Eli Lilly shared early long0term data for 10 patients on its atopic dermatitis drug. Of the 10 patients who responded to lebrikizumab at 16 weeks, eight maintained skin clearance at one year on the two-week or four-week regimen, Lilly reported following positive Phase III results.
- Aiming to jump ahead of Big Pharma heavyweights in the setback-laden C. difficile race, Seres is barreling forward with its own microbiome treatment after staking a late-stage win. Results from an open-label extension study suggested its drug spurred a sustained clinical response in 91.3% of patients at eight weeks and 86% at 24 weeks, confirming data from an earlier trial.
- A year after a Supreme Court opinion put the final nail in the coffin for Amarin’s fish-oil heart drug, the biotech is making some changes to keep its doors open. Now that those blockbuster dreams are quashed, it will be cutting 65% of its US commercial staff, while also chopping overall expenses and “refining” its R&D strategy. Its CFO is among the ones to go. All of this will save $100 million over the next year and keep Vascepa alive, mostly in Europe. And the UK’s NICE fueled those dreams by agreeing to cover the drug
- Sanofi is facing down a strike threat in Korea amid an increasing number of confrontations between Big Pharma and their labor unions over pay demands. A Korean publication cites labor officials who have been unhappy over the company’s offer of a 1.5% increase in pay, citing inflation as well as rising sales during the pandemic.
- Following a disappointing data reveal and subsequent stock drop late last year, Radius Health is now facing an activist attack from two minority investors aiming to right the ship. Velan Capital Investment Management and Repertoire Partners filed their proxy statements in a bid to nominate a slate of three new board members at Radius’ annual shareholder meeting next month.
- The biotech bear market continues to put pressure on small and mid-cap companies, with cancer-focused Vincerx now undergoing a shift. Just a little less than two years after it went public via a SPAC, and after shares fell more than 80% in 2022, Vincerx said it would lay off 33% of its staff as part of an effort to get its lead program through two Phase I studies.
- Beefing up its neuro pipeline in the shadow of Aduhelm, Biogen struck a deal with Canadian biotech Alectos Therapeutics to develop a drug aimed at restoring lysosome function, adding another candidate to its Parkinson’s efforts. The deal, which centers around GBA2, involves $15 million upfront and hundreds of millions more in potential milestones.
- Suffering biotech Yumanity has found that “strategic alternative” it started searching for early this year as its share price shriveled, forcing deep staff cuts. It will sell off most of its pipeline — including a Phase I Parkinson’s drug and discovery-stage neuroscience candidates — to J&J for $26 million in cash. As for the rest of the company, it’s reverse merging with the private biotech Kineta, which will wind up with the public listing and one Merck-partnered program.
- For Alex Zhavoronkov, the recent biotech market downturn is, in fact, a good thing because it’s crystalizing the winners in the AI drug discovery world — his company, Insilico, being one of them in his view. Proud as ever about the $60 million round he just raised, the CEO is adding robotic labs to his vision for the future of how drugs are made.
- Several months after tying the bow with Sanofi, French-US AI player Owkin announced its next deal with Big Pharma, collaborating with Bristol Myers Squibb in cardiovascular disease and using its federated learning platform to improve the pharma’s clinical trial optimization and design. It’s grabbing $80 million to kick things off, money that will be channeled into data generation.
- Having been involved in a number of attrition task force efforts during his tenure as European R&D chief at Pfizer, David Roblin reckons there’s a different way to go through the R&D process — with machine learning and new technologies like single-cell transcriptomics. That’s why he’s jumping on as CEO of Relation Therapeutics, which closed a $25 million seed round to build a “second to none” platform of integration.
CELL & GENE TX
- Tessa Therapeutics in Singapore has been through multiple raises over the last decade for its cell therapy R&D work. But with US-based VC Polaris stepping in to lead the new $126 million round, the biotech is calling this new one a Series A. “I think there’s no way to sugarcoat this,” the CEO says. “We are repositioning the company.”
- En route to meeting with the FDA later this year on potential registration strategy for its allogeneic CAR-T, Precision Biosciences is out with new interim Phase I/IIa clinical data on the lead program sporting a high rate of complete responses. But the biotech will have to shore up safety concerns of its CD-19 directed drug as four deaths were reported in a Phase I/IIa trial.
- Weeks after sharing impressive early data on its first trial for an off-the-shelf CAR-T therapy, Caribou Biosciences is following up with results from a sixth patient who had an initial complete response but saw their cancer progress three months later. And it’s escalating the dose to see if it can make the treatment more durable.
- Amid a push for more in-house capacity, gene therapy player Regenxbio opened a new facility at its campus in the Washington DC suburb of Rockville, MD. Built in a year, the $65 million, 132,000-square-foot GMP facility will enable the company to boost its manufacturing of NAV Technology-based adeno-associated virus, or AAV, vectors at scales up to 2,000 liters.
- The father-son duo behind Teneobio is back with another biotech, comprising three bispecific antibodies that Amgen didn’t want when dishing out $900 million upfront to buy it out last year. Technically, Ancora Biotech is three shell companies, one for each of its antibodies or “Teneo babies,” that could either go public or be sold off individually. Lightspeed and SR One are backing Ancora with $60 million.
- David Baker, one of the biggest names in the protein design space, is throwing his weight behind another biotech — one that seeks to take his famed work in protein folding and extend it further into drug discovery and development. CHARM Therapeutics, based out of the UK, launched with $50 million and a protein and ligand prediction platform dubbed DragonFold.
- Looking to circumvent the obstacles tripping up the viral vectors that carried the first generation of gene therapies into the clinic by using non-viral delivery, Code Biotherapeutics raised $75 million, courtesy of a group of blue-chip investors, to push two programs into IND-enabling studies. Led by GSK BD vet Brian McVeigh, Code Bio has a Takeda deal under its belt.
- San Francisco Bay’s Anagenex emerged from “semi-stealth,” seeking to create a closed feedback loop on small molecule drug development and securing $30 million via a Catalio-led Series A. CEO Nicolas Tilmans added that it seeks to take a sort of directed evolution approach, looking to refine its library of compounds for a specific target over and over again and improve, alluding to evolutionary biologist Charles Darwin’s concept known as Darwin’s finches.
- Looking to catch the radiopharma wave, Berlin-based Ariceum Therapeutics secured $26.7 million as it starts with a team and assets from Ipsen. The lead program is a peptide derivative, and execs argue that working with a Phase II clinical compound gives them an edge over others.
- Degron Therapeutics, a transpacific biotech focused on molecular glues, scored $22 million in Series A funds as it works to vie for Big Pharma’s attention. Founded just last year out of Shanghai Tech University, the biotech boasts of a library of about 6,000 potential molecular glues.
- Despite the bear market creating ongoing struggles in the biotech sector, Tim Lu’s Senti Bio is charging ahead with the completion of its SPAC deal. But it’s crossing the finish line with a much lower cash haul than originally planned as SPAC investors chose to cash out.
- Psychedelics upstart Eleusis, on the other hand, axed its SPAC deal with Silver Spike, citing “current unfavorable market conditions.” The deal would have given the nine-year-old biotech about $288 million to bankroll human trials of a psilocybin-based IV treatment and fuel the expansion of Eleusis’ subsidiary overseeing psychedelic drug therapy clinics.
- Amid a struggling public market for biotechs, European venture capital firm Forbion drummed up an initial close of €470 million ($504 million) for its second growth fund meant to boost late clinical-stage biotechs. This time around, it will be looking beyond pharma spinouts and private rounds to scout “public opportunities or undervalued assets.”
- Michelle Dipp and Jennifer Lum want to focus on the things in biotech that are often sidelined: manufacturing, diagnostic tests, software — the tools needed to produce new drugs. Their first fund at Biospring Partners netted $245 million, and they’ve already invested in a couple of companies.
- Only a handful of biotechs are going after LILRBs, components of the innate immune system. But after an initial crop of data out of Merck in autumn 2020, more interest sprung up in the area, and a former Merck exec has secured $74 million to take his Zurich-area biotech ImmunOs Therapeutics’ lead program into a Phase Ia study.
- With the help of RA Capital, Philly biotech Mineralys Therapeutics got its second VC infusion, worth $118 million courtesy of a Series B after breaking out of stealth with $40 million just over a year ago. With a consortium of other investors tagging along for the ride, the biotech is currently focusing on one asset for hypertension — and putting its nose to the grind to accelerate R&D efforts.
- One of the basic lessons in science class is that mitochondria act as the powerhouse of the cell. But LUCA Science, a Japanese biotech, is looking to take it a step further, harnessing the power of mitochondria to eventually create therapies for organ and tissue repair. CEO Rick Tsai, a Merck and Allergan vet, just closed a $30.3 million Series B.
- A panel of FDA’s outside experts recommended 21 to 0, with one member abstaining, that the agency give emergency use authorization for Novavax’s two-dose Covid-19 vaccine for people aged 18 years and older. The advisors’ vote of confidence was delivered days after the FDA’s scientists determined the vaccine to be effective but with the caveat of potential rare heart inflammation. But unlike its peers, which all received FDA clearance a day after the adcomm, Novavax will have to wait for the agency’s review of manufacturing updates.
- Moderna says the lead candidate for the fall 2022 Covid booster shot has emerged as early one-month data suggest that a bivalent booster vaccine targeting both Omicron and the original strain is more effective than its current shot in a Phase II/III trial with over 700 participants.
- After months upon months of negotiations within the World Trade Organization on a Covid-19 vaccine IP waiver, organization leadership says that a deal may be in place, soon. But the critics keep piling up. A handful of pharma advocacy and lobbying groups decried an IP waiver deal, arguing that it’s unnecessary and threatens to quash innovation.
- J&J’s troubles with Emergent BioSolutions are far from over. The embattled contract manufacturer, which trashed tens of millions of J&J’s Covid-19 vaccine doses because of its contaminated Baltimore plant, is now telling J&J that it will have to pay somewhere in the range of $125 million to $420 million for trying to terminate their manufacturing contract.
- While Moderna and Pfizer have taken much of the limelight when it comes to Covid-19 vaccines, AstraZeneca’s boss is standing by his company’s development efforts. In an interview with the BBC, Pascal Soriot claimed his company’s Covid-19 vaccine has managed to save a million lives despite facing setbacks and said, “I don’t think I would do anything differently from what we did.”
- Without admitting to any wrongdoing, Bristol Myers Squibb agreed to pay almost $11 million to settle allegations filed in a California district court that it took part in an unlawful scheme with other pharma companies like Gilead and Janssen to protect their HIV drug profits while slowing generic competition.
- Novo Nordisk is in federal court, thanks to the Equal Employment Opportunity Commission. 62-year-old Deborah Hunter, an obesity care specialist employed at the pharma, accused Novo of age discrimination when she originally got passed over for a lateral transfer in 2018. While Novo Nordisk found that a manager violated company policy, Hunter was never offered the transfer.
- Three Republican and three Democrat senators called on the US Patent and Trademark Office to attack pharma patent thickets before they start. The letter points to these patent thickets, Specifically, the lawmakers ask that the PTO consider changes to its regulations and practices “to address these problems where they start, during examination” in the pre-issuance stage.
- The new GSK — which, for the first time in its 300-year history, is no longer in the consumer healthcare business — has a new look to go with its new strategy and brand identity. Endpoints MarketingRx editor Beth Bulik goes behind the scenes to shed light on how the company went to its employees to define its new culture.
- The FDA’s Office of Prescription Drug Promotion slapped its third untitled letter of the year onto New Jersey-based Althera Pharmaceuticals, saying the biotech’s DTC ad — which came in the form of a pamphlet — created a misleading impression about the safety profile of its cholesterol drug Roszet (rosuvastatin and ezetimibe) and combined study results in an unorthodox way.
- More than 3,000 Latinos in the US are living with cystic fibrosis, but many of them don’t fit the mold of a typical patient. Roche’s Genentech is hoping to change that and drive awareness in the Latino community with its new “Somos La Gran Familia FQ” campaign. Working with the Bonnell Foundation, Genentech created a CF hub website specifically for Latino families, patients and caregivers.
- J&J’s Janssen ambassadors living with HIV are the “Positively Fearless” campaign advocates the company hopes will lead the way for others. As part of the next iteration, Janssen is planning a media tour with two of the ambassadors, Daniel Garza and Kamaria Laffrey, talking to TV and radio stations across the country about the campaign and their lived experiences with HIV.
- CSL Behring is chronicling the story of hemophilia with patients, caregivers, doctors and researchers through photography — and the lens of renowned UK photographer Rankin. Best known for his distinctive portraits of famous faces and fashion figures, Rankin’s “Portraits of Progress” series features everyday people of the hemophilia community.
- As Akili Interactive preps its ADHD video game therapy for launch, it’s tapping commercial veteran Matt Franklin to lead the way. Franklin, whose most recent work is with diagnostics companies, will join Akili as president and chief operating officer with a focus on the launch and marketing of EndeavorRx, its FDA-approved cognitive therapy for attention deficit hyperactivity disorder.
- Roche is throwing its support behind bladder cancer awareness with a social media campaign to help address the stigma around the disease; Supernus highlights how kids go from distracted to focused in its first TV ad for Qelbree non-stimulant ADHD med; Big Pharmas land on the annual list of best places to work for recent graduates; and more tidbits await in the MarketingRx roundup.
- The House overwhelmingly passed a package of legislation that will reauthorize FDA user fee programs — funding agency reviews of drugs, medical devices, generics and biosimilars — as well as other attached reforms, setting up what is expected to be some heavy negotiating with the Senate as the two sides have several major differences.
- It’s been almost 10 months since the FDA granted Covis Pharma a hearing to review its controversial preterm birth drug Makena, which won an accelerated approval but failed its confirmatory trial, and still the company and FDA are wrangling over the details of that hearing. In a new letter, Covis lawyers are now objecting to the inclusion of an unfavorable study.
- The EMA released a new list of critical medicines to battle the ongoing pandemic, which will put the market authorization holders for these Covid-19 vaccines and drugs on the hook for regularly updating the EMA with data on potential or actual shortages and available stocks, forecasts of supply and demand. Member states will also have to provide regular reports on estimated demand on a national level.
- Missouri-based Nostrum Pharmaceuticals, once at the center of a Shkreli-esque generic drug pricing scandal, just lost its chance to challenge the FDA’s complete response letter for its asthma drug as a court ruled that CRLs aren’t technically final rejections, creating a “statutory barrier” to hearing Nostrum’s petition.
- As Pfizer is continuing to double down on its Paxlovid efforts, more room at its facility in Michigan will now be required. The pharma will be committing $120 million to its 1,300-acre manufacturing facility in Kalamazoo, MI to enable US-based production in support of its Covid-19 oral antiviral, with an expansion in the production of API and RSM.
- Astellas is the latest to pitch its tent in the small city of Sanford, NC. The company’s gene therapy branch, which came out of the acquisition of Audentes in 2019, opened a new manufacturing facility in the city, comprising 135,000 square feet and costing about $100 million.
- CSL’s flu vaccine-focused subsidiary Seqirus completed a new facility expansion at its site in Holly Springs, NC, a suburb of Raleigh. The expansion, which started in 2018, cost the company $156 million and will add around 80 jobs to the area. It is designed to support the formulation and fill-finish of its cell-based flu vaccines in pre-filled syringes for global distribution.
- As it doubles down on manufacturing, Samsung Biologics landed a contract with Novartis worth $81 million, according to a regulatory filing. While the companies are keeping most of the details under wraps, the deal marks a sizable portion of Samsung sales.
- Eli Lilly is being brought to court in New Jersey by a former employee who is seeking damages after acting as a whistleblower. Amrit Mula, a former associate director of employee relations at Lilly’s plant in Branchburg, NJ — which has drawn the ire of the FDA and the DOJ — alleged as she investigated complaints of violations, Lilly kept telling her to stop and harassing her.
- EQT’s private equity fund, EQT X, and Mubadala Investment Company, the investment branch of the United Arab Emirates, are making a big investment in cold chain management through their $3 billion deal to buy Envirotainer, a temperature-controlled supply chain provider for the transportation of biopharmaceuticals, from Cinven and Novo Holdings.
- A Form 483 is shining a light on what exactly got Indian drug manufacturer Aurobindo Pharma in trouble with the FDA. During an inspection at its formulation plant, investigators found an unexplained discrepancy and a failure of a batch of its components to meet any of its specifications.
- The FDA’s inspection of Sun Pharma’s facility in Halol, India, meanwhile, raised several concerns around sanitation and improper controls, among other infractions, according to its Form 483. It’s not the first time Sun, or this particular site, has run into problems.
- Swiss manufacturer Lonza expanded its presence in Bend, OR, an area more known for its outdoor amenities and the last remaining Blockbuster Video store. The expansion adds to its small molecules facility, which also serves as the company’s center of excellence for bioavailability enhancement and inhaled delivery for its small molecules business unit.
- Moderna’s Cinderella story — changing the world, saving lives while getting rewarded with a gigantic valuation with its Covid-19 vaccine — is getting a scary rewrite on Wall Street. Fearing faster than expected revenue drop, a top analyst is pointing to a “transformative” BD deal as the way to go.
- The FTC is turning up the heat on the drug industry’s middlemen, launching an investigation into pharmacy benefit manager practices and the effect on drug prices. The move comes just a few months after a different study proposal failed to gain enough support among the FTC commissioners. But with a revamped study and a new appointee, the latest vote was unanimous.
- When President Joe Biden reignited the Obama-era Cancer Moonshot initiative four months ago, scientists wondered where the money would come from. The CDC is now doling out the first installment of a five-year, $1.1 billion grant to get things going, channel the funding through three national programs.
- About a month after the monkeypox outbreak emerged in Europe, Bavarian Nordic says it’s seeing “overwhelming” interest in its smallpox vaccine Jynneos, including a new contract with Canada worth $56 million and an expanded deal with the US. As it continues talks with other countries, the Danish company also updated its 2022 sales figures again.