Sen. Mitch McConnell (R-KY) at the Capitol (J. Scott Applewhite/AP Images)

Mitch Mc­Connell, top Re­pub­li­cans ques­tion Biden on get­ting ahead of FDA on Covid-19 boost­ers

Sen­ate Mi­nor­i­ty Leader Mitch Mc­Connell, Sen­ate Health Com­mit­tee rank­ing mem­ber Richard Burr and oth­er top Re­pub­li­cans are ques­tion­ing the Biden ad­min­is­tra­tion’s de­ci­sion to get out in front of the FDA and an­nounce that Covid-19 vac­cine boost­ers would be ready for ad­min­is­tra­tion by this week.

While Burr praised the FDA’s EUA for the boost­ers Wednes­day evening, the Re­pub­li­cans ear­li­er in the day called on White House coro­n­avirus re­sponse co­or­di­na­tor Jef­frey Zients to re­lease an up­dat­ed strat­e­gy on lever­ag­ing vac­cines to end the pan­dem­ic and to clar­i­fy what ex­act­ly hap­pened with the pre­ma­ture an­nounce­ment on the boost­ers.

Last month, the Biden ad­min­is­tra­tion con­tro­ver­sial­ly planned for the boost­ers to be avail­able for all be­gin­ning this week, be­fore any of the fol­low-on shots had been au­tho­rized for use. Since then, his top Covid of­fi­cials have at­tempt­ed to down­play the cer­tain­ty of the plan. Two top FDA vac­cine of­fi­cials al­so al­leged­ly re­tired in part be­cause of con­cerns with this po­lit­i­cal pres­sure to meet Biden’s time­line.

Sur­geon Gen­er­al Vivek Murthy said in a press brief­ing last Fri­day: “The an­nounce­ment in Au­gust, and cer­tain­ly in the time since then, we have al­ways said that this ini­tial plan would be con­tin­gent on the FDA and the CDC’s in­de­pen­dent eval­u­a­tion.” That eval­u­a­tion from the FDA led to a more re­strict­ed EUA than Pfiz­er ini­tial­ly sought.

The Re­pub­li­cans ques­tioned Zients on this point in a let­ter Wednes­day: “Why did the White House an­nounce vac­cine boost­ers would be avail­able to all Amer­i­cans pri­or to any sci­en­tif­ic or reg­u­la­to­ry work be­ing done to ap­prove or au­tho­rize such boost­ers?” They al­so asked which stud­ies are be­ing con­duct­ed and re­lied up­on to de­ter­mine that boost­ers are nec­es­sary for all Amer­i­cans.

And the Re­pub­li­can sen­a­tors ques­tioned HHS’ new plan to con­trol dis­tri­b­u­tion to cer­tain states seek­ing ac­cess to mon­o­clon­al an­ti­body treat­ments for Covid-19.

Last week, HHS an­nounced it would tran­si­tion from a di­rect or­der­ing process to a state/ter­ri­to­ry-co­or­di­nat­ed dis­tri­b­u­tion sys­tem, sim­i­lar to what was used when mAbs were first dis­trib­uted from No­vem­ber 2020 through Feb­ru­ary 2021.

Un­der the new sys­tem, HHS will de­ter­mine the week­ly amount of mAbs each state and ter­ri­to­ry re­ceives based on Covid-19 case bur­den and mAb uti­liza­tion. State and ter­ri­to­r­i­al health de­part­ments will then se­lect sites to re­ceive prod­uct as well as the amount each site re­ceives. That places more of the bur­den on the fed­er­al gov­ern­ment to fig­ure out which states are in great­est need.

But the change comes amid a grow­ing de­mand and re­cent in­crease in the preva­lence of the Delta vari­ant, and as HHS an­nounced ear­li­er in the month that it was look­ing in­to mAb short­ages and or­ders.

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.

Credit: Shutterstock

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.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

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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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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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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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

UP­DAT­ED: As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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