Controversial Duchenne MD player Solid Bio takes another hit, laying off staffers in a bid to weather FDA hold

January 9, 2020 09:18 AM EST

Controversial Duchenne MD player Solid Bio takes another hit, laying off staffers in a bid to weather FDA hold

John Carroll

Editor & Founder

With their gene therapy program for Duchenne muscular dystrophy frozen in regulatory limbo with no evident sign of a near-term thaw, Solid Biosciences $SLDB is axing staff, bidding top execs goodbye and circling the wagons in a bid to survive the storm.

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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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ENDPOINTS CAREERS

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 25, 2022 09:00 AM EDT

R&D

GSK says its drug for chronic hep B could ‘lead to a functional cure’ — but will it be alone or in combination?

Lei Lei Wu

News Reporter

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

June 24, 2022 07:37 AM EDTUpdated 02:31 PM

R&D

Coronavirus

Sanofi, GSK tout 72% Omicron efficacy in PhIII trial of next-gen, bivalent shot — with an eye to year-end rollout

Amber Tong

Senior Editor

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

June 23, 2022 11:19 AM EDTUpdated 12:51 PM

R&D

Cell/Gene Tx

In troubled Huntington’s space, uniQure’s gene therapy shows early promise

Lei Lei Wu

News Reporter

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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ENDPOINTS CAREERS

Product Sales Manager

ImmunityBio

Remote

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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.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

June 24, 2022 12:28 PM EDTUpdated 01:33 PM

Law

Following SCOTUS decision to overturn abortion protections, AG Garland says states can't ban the abortion pill

Zachary Brennan

Senior Editor

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”