President Biden (AP Images)

Biden sets a 45-day count­down for 'com­pre­hen­sive' plan to tack­le drug pric­ing — while cham­pi­oning some fa­mil­iar poli­cies

Should the phar­ma in­dus­try be brac­ing for new bat­tles on drug pric­ing?

In an ex­ec­u­tive or­der that might serve as a pre­lude for what’s to come, Pres­i­dent Joe Biden spot­light­ed some fa­mil­iar pol­i­cy pro­pos­als while di­rect­ing the HHS to “is­sue a com­pre­hen­sive plan with­in 45 days to com­bat high pre­scrip­tion drug prices and price goug­ing.”

The EO an­nounce­ment comes on the heels of a call by House Speak­er Nan­cy Pelosi to at­tach drug pric­ing re­form to the cur­rent bud­get bill. The cen­tral fig­ure be­hind a sweep­ing bill to tack­le drug prices that’s passed the House, Pelosi pub­licly re­ject­ed the in­dus­try’s ar­gu­ment that low­er­ing prices would harm in­no­va­tion.

Biden’s pre­lim­i­nary plan, re­leased Fri­day af­ter­noon, was paint­ed in much broad­er strokes, and no­tably ex­clud­ed the most rad­i­cal ideas, such as em­pow­er­ing Medicare to di­rect­ly ne­go­ti­ate prices or peg­ging US list prices to an in­ter­na­tion­al in­dex.

Rather, fram­ing the main is­sue as a lack of com­pe­ti­tion, Biden fo­cused on three spe­cif­ic mea­sures en­gag­ing a trio of gov­ern­ment agen­cies: The FDA shall work with states and tribes to safe­ly im­port drugs from Cana­da; the HHS shall in­crease sup­port for gener­ics and biosim­i­lars; and the FTC shall ban “pay for de­lay” or sim­i­lar types of arrange­ments de­signed to sti­fle new mar­ket en­trants.

From the White House:

One strat­e­gy that drug man­u­fac­tur­ers have used to avoid com­pet­ing is ‘pay for de­lay’ agree­ments, in which brand-name drug man­u­fac­tur­ers pay gener­ic man­u­fac­tur­ers to stay out of the mar­ket. That has raised drug prices by $3.5 bil­lion per year, and re­search al­so shows that ‘pay for de­lay’ and sim­i­lar deals be­tween gener­ic and brand name man­u­fac­tur­ers re­duce in­no­va­tion — re­duc­ing new drug tri­als and R&D ex­pen­di­tures.

All three di­rec­tives echo poli­cies or ap­proach­es that have been cham­pi­oned by his pre­de­ces­sor Don­ald Trump or oth­er politi­cians across the aisles.

With the ex­cep­tion of his con­tro­ver­sial en­dorse­ment of a Covid-19 vac­cine IP waiv­er, Biden has been seen as cor­dial to the bio­phar­ma in­dus­try, es­pe­cial­ly in con­trast with Trump’s of­ten con­fronta­tion­al style. The gov­ern­ment spent the past few months main­ly ty­ing ad­min­is­tra­tive loose ends — his HHS with­drew two re­quests for pro­pos­als days ago on the reim­por­ta­tion of in­sulin and per­son­al im­por­ta­tion of pre­scrip­tion drugs, cit­ing a dearth of re­sponse — leav­ing Con­gress to sort out pol­i­cy po­si­tions.

That could well change in 45 days when the HHS lays out its plan. Or not.

The largest phar­ma play­ers, a fact sheet on the new EO states, reaps av­er­age an­nu­al prof­its of 15% to 20%, much high­er than the 4% to 9% re­port­ed by the largest non-drug com­pa­nies.

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.

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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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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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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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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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(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.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.