PhI may still be a killing field of fail­ure but PhI­II suc­cess rates have surged, sig­nal­ing tec­ton­ic shifts in bio­phar­ma R&D

Those new drugs you see entering the clinic with such promise and pride still suffer from a consistently meager success rate. And while Phase II success rates have edged up only slightly, the odds have improved substantially for the drugs that are now going into Phase III.

That’s the bottom line from a new analysis done by CMR International, which has been sizing up the success/failure rates of 30 big and medium-sized biopharmas, a group that includes 16 of the top 20 players.

In an analysis of the most recent set of data stretching from 2010 to 2018, published in Nature Reviews, their analysts found that the success rate of drugs starting out in Phase I has been consistently bumping around in the mid-single digits for the past decade. Starting in 2010 through 2017 that rate has tracked steadily at a poor 6% to 7%.

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Dr. Gabriel Kremmidiotis, Chief Scientific Officer (center) heads up the biotech ClinicReady team of scientific and medical affairs specialists with a 20-year track record. Dr. Jorgen Mould Avance Clinical Scientific Affairs Specialist (left) and Yvonne Lungershausen, Avance Clinical’s CEO.

How Clini­cReady by Aus­tralian CRO Avance Clin­i­cal de­liv­ers pre­clin­i­cal project man­age­ment and sci­en­tif­ic and reg­u­la­to­ry ad­vice to get biotechs in­to clin­ic faster.

Avance Clinical has formed a dedicated scientific and regulatory affairs service, ClinicReady by Avance Clinical, in response to increased demand from biotechs for preclinical study management and scientific and regulatory advice to take their products to first-in-human trials.

The highly regarded Avance Clinical scientific and regulatory team, which has been advising biotech clients on their drug development for more than 20 years, is now a dedicated ClinicReady service under the Avance Clinical banner.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Hans Schambye

Galec­to reaps $64M to bring lead drug across IPF fin­ish line, while mak­ing moves in NASH and be­yond

Back in 2018, Hans Schambye raised $90 million to kick off a late-stage trial that could put Galecto Biotech’s lead drug on the final stretch toward approval for idiopathic pulmonary fibrosis. Two years later, he’s collected another $64 million to complete it.

The Copenhagen-based company has managed to continue recruitment for the 450-patient trial in spite of the pandemic, the CEO told Endpoints News, with data expected by the middle of 2022.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Image credit: AP

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.