New House bill aims to shore up US API pro­duc­tion in re­sponse to pan­dem­ic short­ages

Amidst heavy de­mand for drugs and vac­cines through­out the world, a new House bill, dubbed the PRE­PARE ACT of 2021, would cre­ate a na­tion­al stock­pile of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents and pre­vent sup­ply chain short­ages.

The bill, in­tro­duced by Reps. Abi­gail Span­berg­er (D-VA), and David McKin­ley (R-WV), would en­sure the coun­try has a stock­pile of APIs need­ed to man­u­fac­ture gener­ics for a list of es­sen­tial med­i­cines that would be de­ter­mined by a group that in­cludes the FDA com­mis­sion­er, the as­sis­tant sec­re­tary for pre­pared­ness and re­sponse and the sec­re­tary of de­fense. The FDA com­mis­sion­er has al­ready iden­ti­fied a list as of Oct. 30, which would be up­dat­ed at least once a year.

Rou­tine threat as­sess­ments would al­so be es­tab­lished, with each tak­ing in­to con­sid­er­a­tion the lack of ex­ist­ing ca­pac­i­ty, the cur­rent sup­ply of med­i­cines or API, the po­ten­tial for in­creased de­mand in a pub­lic health emer­gency and whether or not there are few­er than two man­u­fac­tur­ers of the gener­ic med­i­cine or API.

The bill aims to curb a US over­re­liance on API from oth­er coun­tries. Gener­ic drugs make up 90% of the pre­scrip­tions filled in the US, a press re­lease from the Sen­ate says, and 87% of API fa­cil­i­ties are out­side the US.

Span­berg­er spoke about the res­o­lu­tion in front of a crowd at Vir­ginia Com­mon­wealth Uni­ver­si­ty. The school’s en­gi­neer­ing de­part­ment has been rec­og­nized for lead­ing ef­forts to im­prove gener­ic drug man­u­fac­tur­ing through its Med­i­cines for All In­sti­tute.

“Our bill is a step for­ward to­ward fix­ing these is­sues by cre­at­ing a list of es­sen­tial med­i­cines and en­sur­ing that the sup­ply chains for these drugs are based here in the Unit­ed States, us­ing the most up-to-date tech­nol­o­gy,” Span­berg­er said.

The rep­re­sen­ta­tive from Vir­ginia has been grilled in re­cent weeks about how she would find fund­ing to low­er the cost of pre­scrip­tion drugs and sup­port care­givers.

The bill was in­tro­duced in the Sen­ate by Bill Cas­sidy (R-LA) and Sher­rod Brown (D-OH), in mid-Sep­tem­ber.

“COVID re­mind­ed us that we are too re­liant on for­eign coun­tries for gener­ic drugs and phar­ma­ceu­ti­cal prod­ucts. This bill brings enough pro­duc­tion back to the U.S. so Amer­i­ca is bet­ter pre­pared,” Cas­sidy said in a press re­lease.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

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As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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