FDA offers new guidance to help generic drug developers get to market more quickly

January 27, 2022 01:58 PM EST

FDA offers new guidance to help generic drug developers get to market more quickly

Zachary Brennan

Senior Editor

The FDA on Wednesday released a trio of new guidance documents under its Drug Competition Action plan to help the generic drug industry with a more efficient and transparent generic drug review process.

One of the two final guidances released deals with how the agency issues and uses information requests (IRs) and discipline review letters (DRLs) during the assessment of an original generic drug application, also known as an abbreviated new drug application or ANDA.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

June 28, 2022 12:50 PM EDTUpdated 04:26 PM

R&D

Novartis details plans to axe 8,000 staffers as Narasimhan begins second phase of a global reorg

John Carroll

Editor & Founder

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000 jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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June 29, 2022 06:00 AM EDT

Pharma

Sanofi to cut insulin prices for uninsured from $99 to $35, matching the insulin cap coming through Congress

Zachary Brennan

Senior Editor

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

June 28, 2022 07:17 AM EDT

Pharma

In Focus

How prepared is biopharma for the cyber doomsday?

Amber Tong

Senior Editor

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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ENDPOINTS CAREERS

Director of Quality Assurance

ImmunityBio

Dunkirk, NY, USA

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Bob Nelsen (Lyell)

June 29, 2022 07:05 AM EDT

People

Financing

As bear market continues to beat down biotech, ARCH closes a $3B early-stage fund

Max Gelman

Senior Editor

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

June 28, 2022 02:22 PM EDTUpdated 03:44 PM

Pharma

FDA+

Manufacturing

Aurobindo Pharma receives warning letter from India's SEC following more FDA question marks

Tyler Patchen

News Reporter

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

June 28, 2022 09:57 AM EDT

Pharma

FDA+

Spero’s UTI candidate gets the CRL hammer as the company falls into penny stock status

Tyler Patchen

News Reporter

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Lina Gugucheva, NewAmsterdam Pharma CBO

June 28, 2022 08:00 AM EDT

Deals

Pharma group bets up to $1B-plus on the PhIII resurrection of a once dead-and-buried LDL drug

John Carroll

Editor & Founder

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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ENDPOINTS CAREERS

Product Sales Manager

ImmunityBio

Remote

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(AP Photo/Gemunu Amarasinghe)

June 28, 2022 02:27 PM EDTUpdated 04:38 PM

Pharma

Some pharma companies promise to cover abortion-related travel costs — while others won't go that far yet

Nicole DeFeudis

Editor

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Bristol Myers Squibb (Alamy)

June 28, 2022 01:57 PM EDT

Pharma

CVS resumes coverage of blockbuster blood thinner after price drop follows January exclusion

Zachary Brennan

Senior Editor

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”