Novartis returns to appellate court, requesting rehearing and reversal in Gilenya patent case

July 25, 2022 02:50 PM EDT

Novartis returns to appellate court, requesting rehearing and reversal in Gilenya patent case

Paul Schloesser

Associate Editor

Novartis may have suffered a setback in court over its blockbuster neuroscience drug Gilenya, but the pharma giant isn’t done fighting for it.

A month after the US Court of Appeals for the Federal Circuit ruled 2-1 against Novartis in a patent infringement case, the Swiss pharma giant filed a motion requesting to be heard either by a new panel or en banc, which means all judges of the court hear the case, instead of 1 or a panel of 3. By law, there are 12 judges on the court.

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MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

Innovative MedTech Demands Specialist Clinical Trial Regulatory Affairs and Design

Tom Avery

Scientific and Medical Affairs Specialist, Medical Devices

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

August 8, 2022 02:58 PM EDT

Pharma

Despite falling Covid-19 sales, BioNTech maintains '22 sales guidance

Paul Schloesser

Associate Editor

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

August 8, 2022 02:15 PM EDT

FDA+

Law

With drug pricing almost done, Congress looks to wrap up FDA user fee legislation

Zachary Brennan

Senior Editor

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

August 8, 2022 01:58 PM EDTUpdated 02:58 PM

Pharma

FDA+

AstraZeneca and Daiichi Sankyo sprint to market after FDA clears Enhertu in just two weeks

Nicole DeFeudis

Editor

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

August 8, 2022 07:34 AM EDTUpdated 11:57 AM

Deals

Updated: Pfizer scoops up Global Blood Therapeutics and its sickle cell therapies for $5.4B

Amber Tong

Senior Editor

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

August 7, 2022 08:02 AM EDTUpdated 19 hours ago

R&D

Pharma

UPDATED: In a fresh disappointment, Amgen spotlights a major safety issue with KRAS combo

John Carroll

Editor & Founder

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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August 8, 2022 02:14 PM EDTUpdated 02:33 PM

Pharma

GSK and IQVIA launch platform of US vaccination data, showing drop in adult rates

Tyler Patchen

News Reporter

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Boston, MA, USA

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August 8, 2022 02:05 PM EDT

Pharma

Marketing

AbbVie surveys emotional impact of chronic leukemia condition, finds 'roller coaster' of emotions

Beth Snyder Bulik

Senior Editor

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

August 8, 2022 07:22 AM EDTUpdated 10:42 AM

Pharma

Law

Senate Dems cling to a simple majority to pass some of the biggest drug pricing reforms ever

Zachary Brennan

Senior Editor

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.