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UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Ail­ing Mallinck­rodt's drug for rare, life-threat­en­ing re­nal con­di­tion clears piv­otal study

Embattled Mallinckrodt — tarnished by a cloud of opioid litigation as well as its controversially expensive Acthar gel — will enjoy its sliver of optimism that comes with a positive pivotal trial.

The UK drugmaker on Thursday unveiled data from a late-stage trial testing the drug, terlipressin, in patients with a life-threatening, progressive rare complication of liver disease that triggers kidney failure called hepatorenal syndrome type 1 (HRS-1), which affects an estimated 30,000 to 40,000 in the United States each year, the company said, adding that patients face a poor prognosis, with a median survival time of less than two weeks and more than 80% mortality within three months.

FDA en­dors­es new reg­i­men for dead­ly drug-re­sis­tant tu­ber­cu­lo­sis ram­pant in de­vel­op­ing world

The bacteria behind tuberculosis do not discriminate — they are all-pervasive, but the highest burden of disease is borne by poorer nations. Like many other forms of bacteria, TB-causing bacteria have rapidly mutated to become drug-resistant — and for those inflicted with these strains, options are limited and prognosis feeble. In a first, the FDA on Wednesday approved a three-drug cocktail developed by a nonprofit organization that is engineered to help those with the stubborn form of TB that has failed to respond to conventional therapy.

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Eli Lil­ly's Taltz beats J&J's Trem­fya in pso­ri­a­sis head-to-head — but the mar­ket­ing brawl is just be­gin­ning

Eli Lilly has come out swinging at J&J, staking out its challenger position in a crowded battle of plaque psoriasis blockbusters.

In a Phase IV head-to-head study with 1,027 patients, Lilly says its IL-17A inhibitor Taltz beat J&J’s IL-23/p19 drug Tremfya on complete skin clearance at week 12 as defined by PASI 100. It’s the first direct comparison of these two classes using PASI 100 as a primary endpoint, Lilly says, though it also shows that Taltz is consistently superior in measures of PASI 50, PASI 75 and PASI 90 at multiple (although not all) time points — comprising a number of “key secondary endpoints.”

CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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As ne­go­ti­a­tions with Eng­land la­bor on, Scot­land re­jects rou­tine use of Ver­tex's cys­tic fi­bro­sis drugs

As the battle between Vertex and England’s National Health Service (NHS) continues — the Scottish NHS has rejected two of the drugmaker’s cystic fibrosis medicines.

The US drugmaker has been locked in negotiation with NICE, which has refused to allow the drug in to England’s NHS until Vertex $VRTX offers it a discount on the treatment’s price tag that would compel the agency to look favorably upon its cost-effectiveness. On Monday, the Scottish NHS spurned two of the company’s medicines — Orkambi and Symkevi — for the same reason, to the dismay of thousands of patients.

Victor Bulto [via Dermatology Education Foundation on YouTube]

Make that 2 new US Big Phar­ma chiefs to­day, as No­var­tis re­makes top team

Today we get two new Big Pharma chiefs for the US market.

This morning GlaxoSmithKline led the way with the news that they recruited Merck KGaA’s Maya Martinez-Davis for the role of US pharma president. And Novartis, which has been remaking its own top ranks, followed by announcing that Fabrice Chouraqui is stepping down from that same role and will be replaced by Victor Bulto, who has championed Cosentyx in the US.

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