8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate

February 13, 2020 04:53 PM EST

8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate

Amber Tong

Senior Editor

CAMELLIA-TIMI 61 was supposed to be the trial that would resolve the FDA’s concerns about Belviq as Eisa investigators showed that the weight loss drug didn’t increase incidences of cardiovascular events. Instead, it unearthed new issues that’s now led to its demise.

At regulators’ request, Eisai said it’s withdrawing both the original and extended release version of Belviq from the US market, where it earned a little more than $28 million from April to December 2019.

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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.

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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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.”

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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.”

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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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.

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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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June 24, 2022 07:03 AM EDT

FDA+

Alarmed by side effect, FDA slaps clinical hold on Sarepta's next-gen Duchenne drug

Amber Tong

Senior Editor

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

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