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Rioters sit under the Surrender of Lord Cornwallis in the Capitol Rotunda (Photo: Saul Loeb / AFP)

Bio­phar­ma lead­ers con­demn mob vi­o­lence on Capi­tol Hill, look­ing to close Trump's chaot­ic chap­ter in Amer­i­can his­to­ry

Some of the leading voices in biopharma have had a difficult time over the last 4 years watching Donald Trump march through American history with an often fractious view of the drug industry. Biopharma leaders and organizations have condemned the administration’s immigration policies and vehemently objected to Trump’s drug pricing proposals. But they also enjoyed the warm embrace of Trump’s Operation Warp Speed in a sprint to develop new vaccines and drugs for Covid-19, with heavy government subsidies, even if the president also accused Pfizer of dragging its feet on their application for an OK to get clear of voting day.

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(Source: Pfizer)

New year, new me: Pfiz­er aban­dons icon­ic 'blue pil­l' lo­go in fa­vor of sleek­er — if more am­bigu­ous — new de­sign

After a breakup, it’s OK to take some time for yourself — revisit that hobby you left behind, start journaling, maybe drop a few pounds. Or, if you’re an iconic pharmaceutical brand, launch that ambitious redesign you’ve planned for years; it’s a new year, after all, and you deserve it.

With the spinoff of its Upjohn unit and branded Viagra in the books, Pfizer is ringing in the new year with a brand new logo — the company’s first redesign in decades — as it looks at a slimmed-down future without the generics yoke around its neck.

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Ludwig Hantson, Alexion via Twitter

So why is Alex­ion pay­ing $100M for a PRV as As­traZeneca lines up their $39B buy­out?

It looks like AstraZeneca may have a bonus waiting once it’s done acquiring Alexion.

Yesterday, Rhythm Pharmaceuticals put out word that the biotech sold their newly won priority review voucher for $100 million — but without identifying the buyer. And then, after the market close, we found out in an SEC filing that the mystery buyer was Alexion.

Alexion has been scooping up new approvals for its Soliris successor, Ultomiris, with an emergency Phase III underway for Covid-19. But there’s not a lot of new drugs in the late-stage pipeline lining up for a run at a quick OK.

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Re­call re­port: Nos­trum ex­pands re­call of di­a­betes drug met­formin af­ter car­cino­gen con­cerns

Generic metformin has been a thorn in drugmakers’ sides for months after a probable human carcinogen was found in tested lots. Now, one of the companies is expanding its recall to another lot of the drug.

Nostrum Laboratories out of Kansas City, MO voluntarily recalled one lot of metformin HCl extended release tablets, USP 750 mg, a type 2 diabetes drug (the generic equivalent to Glucophage tablets) after testing discovered elevated levels of nitrosamine, the probable carcinogen.

Bris­tol My­ers Squibb walks on Op­di­vo's FDA nod for small-cell lung can­cer af­ter mid­dling OS da­ta could­n't back ap­proval

In a pitched battle against Merck’s Keytruda, Bristol Myers Squibb’s immunotherapy headliner Opdivo landed a major salvo with a groundbreaking FDA approval for certain lung cancer patients back in 2018. Since that nod, however, Opdivo has turned out clinical duds in that market, and now Bristol is cutting its losses.

Bristol has agreed to give up Opdivo’s third-line-or-later FDA approval for small-cell lung cancer after confirmatory trials for an accelerated nod in that indication back in 2018 failed to show benefit in extending patients’ lives, the drugmaker said Tuesday.

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Pascal Soriot, Getty

EU reg­u­la­tor says As­traZeneca ap­proval not im­mi­nent, even as Pas­cal So­ri­ot teas­es stronger da­ta

UK regulators are reportedly set to approve AstraZeneca’s Covid-19 vaccine this week, but don’t expect it to be available across the channel anytime soon.

A top EMA official told a Brussels newspaper this week that European authorities have yet to receive all the data necessary for approval from the British Pharma, leaving them unable to render a verdict. Asked why it would be OK’d on the isle, the official, EMA deputy executive director Noël Wathion, said he could only speculate.

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United CEO Martine Rothblatt

With pipeline set­backs mount­ing, Unit­ed snares pri­or­i­ty vouch­er for in­haled for­mu­la­tion of PAH med Ty­va­so

Despite a big lead in pulmonary arterial hyptertension, United Therapeutics is under the gun as it looks to stave off competitors and build a successful expansion over in oncology. So far, those results have been mixed. But now, United is on the cusp of adding a new formulation to its successful Tyvaso franchise that could spur growth.

For a cool price tag of $105 million, United Therapeutics has snared a priority review voucher (PRV) for rare pediatric diseases from Y-mAbs Therapeutics that it intends to use to help take an inhaler version of its hypertension med Tyvaso across the finish line, the company said Monday. The voucher was originally intended for Y-mAbs’ application for Danyelza in neuroblastoma and wasn’t used for the FDA’s approval in November.

President Donald Trump leaving the White House yesterday (Credit: Washington Post)

A fed­er­al judge blocks Don­ald Trump's 'most fa­vored na­tion' drug pric­ing plan as the lease runs out on the White House

Donald Trump will leave the White House without any major drug pricing plan to his name.

A federal judge on Wednesday agreed to issue a temporary restraining order against Trump’s controversial “most favored nation” plan, which Trump tried to push through in an executive order. The plan would have limited Medicare reimbursements to what drug companies are paid in other affluent nations — which is currently far less than the premiums available in the US.

Bristol CEO Giovanni Caforio, AP

Af­ter mul­ti­ple set­backs, Bris­tol My­ers scut­tles Op­di­vo pro­gram for brain tu­mor pa­tients af­ter fail­ing to pro­long lives

Bristol Myers Squibb has seen setback after setback for its chances to bring immuno-oncology blockbuster Opdivo into newly diagnosed brain cancer patients — a sort of holy grail for the field. Despite holding a slim hope Opdivo would turn around its chances, Bristol is ready to call it quits for now.

Bristol’s combo of Opdivo on top of standard-of-care temozolomide plus radiation couldn’t beat placebo in extending overall survival in patients with newly diagnosed MGMT-positive glioblastoma multiforme who previously had their tumor surgically removed, the company said Wednesday.

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Emily Leproust, Twist

Twist Bio­sciences plots its 'fac­to­ry of the fu­ture' in Ore­gon, seeks to ex­pand syn­thet­ic DNA client base

One of the leading players at the forefront of synthetic DNA production, California-based Twist Bioscience has already had a busy 2020. Now, seeking to expand its client base and technology capabilities even further, it’s building its “factory of the future.”

Twist, which manufactures synthetic DNA by writing it on a silicon chip platform, will build a 110,000-square-foot facility near Portland, Oregon, that will more than double its current production capacity by the time the facility is operational in 2022.