UPDATED: Biogen finally publishes PhIII results for Aduhelm as critics chastise low-ranking journal, ‘gentle and unrevealing’ peer review

March 16, 2022 09:29 AM EDTUpdated March 17, 06:34 AM

UPDATED: Biogen finally publishes PhIII results for Aduhelm as critics chastise low-ranking journal, ‘gentle and unrevealing’ peer review

Zachary Brennan

Senior Editor

Biogen quietly announced at a conference in Spain today that a manuscript of the Phase III results for the company’s controversial Alzheimer’s drug Aduhelm has finally been published in a tiny journal with a conflicted chief editor, almost a year after the drug won its accelerated approval.

The manuscript was published Wednesday in the Journal of Prevention of Alzheimer’s Disease, a spokesperson told Endpoints News, pointing to the release’s link to a company presentation today at the 2022 International Conference on Alzheimer’s and Parkinson’s Diseases.

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M&A: a critical driver for sustainable top-line growth in healthcare

Andrew Callaway

Global Head, Healthcare Investment Banking, RBC Capital Markets

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

June 25, 2022 06:00 AM EDT

Weekly

15 LGBTQ leaders in biopharma; Paul Stoffels’ Galapagos revamp; AstraZeneca catches up in ATTR; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

June 27, 2022 03:19 AM EDT

Deals

Ipsen snags an approved cancer drug in $247M M&A deal as another battered biotech sells cheap

John Carroll

Editor & Founder

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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Director of Quality Assurance

ImmunityBio

Dunkirk, NY, USA

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

June 23, 2022 11:53 AM EDT

Pharma

Marketing

AstraZeneca debuts first consumer campaign for its Covid-19 prophylactic Evusheld — and a first for EUA drugs

Beth Snyder Bulik

Senior Editor

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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June 24, 2022 01:57 PM EDTUpdated 02:14 PM

Pharma

Despite a slow start to the year for deals, PwC predicts a flurry of activity coming up

Nicole DeFeudis

Editor

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

June 24, 2022 10:14 AM EDT

Pharma

FDA+

Amryt Pharma submits a formal dispute resolution to the FDA over rejected skin disease drug

Tyler Patchen

News Reporter

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

June 24, 2022 09:48 AM EDT

Pharma

FDA+

Pharma-friendly senator calls on FDA for a third time to show patent protections shouldn't be blamed for high drug prices

Zachary Brennan

Senior Editor

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

ENDPOINTS CAREERS

Product Sales Manager

ImmunityBio

Remote

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June 24, 2022 08:51 AM EDTUpdated 09:45 AM

Pharma

FDA+

EMA signs off on 3 drugs recently rejected by FDA, including BioMarin's new hemophilia gene therapy

Zachary Brennan

Senior Editor

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

June 24, 2022 08:50 AM EDTUpdated 01:56 PM

People

Pharma

Joe Papa resigns as chair of Bausch Health as billionaire John Paulson takes over

Zachary Brennan

Senior Editor

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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