FDA+ roundup: Biden’s scientific leadership in major flux; Cures 2.0 and ARPA-H to be packaged together

February 9, 2022 12:46 PM EST

FDA+ roundup: Biden's scientific leadership in major flux; Cures 2.0 and ARPA-H to be packaged together

Zachary Brennan

Senior Editor

President Joe Biden’s administration is in a scientific pickle.

The White House’s top scientist Eric Lander resigned earlier this week, after demeaning women in his office.

Rob Califf, the White House’s choice to lead the FDA, after a year of silence, is now battling an internal revolt from Democrats that doesn’t have much to do with his résumé.

NIH Director Francis Collins has resigned, with no clear path for a replacement.

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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.

August 12, 2022 12:47 PM EDT

Pharma

FDA+

FDA approves second indication for AstraZeneca and Daiichi's Enhertu in less than a week

Aayushi Pratap

News Reporter

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

August 12, 2022 09:19 AM EDT

R&D

Pharma

Gold for adults, silver for infants: Pfizer's Prevnar 2.0 headed to FDA months after Merck's green light

Kyle LaHucik

Associate Editor

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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ENDPOINTS CAREERS

Chief Scientific Officer

Experimental Drug Development Centre

Singapore

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August 12, 2022 12:39 PM EDT

Pharma

J&J to remove talc products from shelves worldwide, replacing with cornstarch-based portfolio

Nicole DeFeudis

Editor

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

August 12, 2022 12:26 PM EDT

Pharma

Marketing

CSL brings Seqirus, Vifor under parent umbrella brand in identity revamp

Beth Snyder Bulik

Senior Editor

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Benjamin Oakes, Scribe Therapeutics CEO

August 12, 2022 07:46 AM EDTUpdated 01:01 PM

Cell/Gene Tx

CEO of Doudna spinout: Within five years, genome editors will have a 'really big impact' on patients' lives

Zachary Brennan

Senior Editor

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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August 12, 2022 01:14 PM EDT

Manufacturing

Abbott pumps $450M+ into new Ireland-based manufacturing site project and hiring spree

Tyler Patchen

News Reporter

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

ENDPOINTS CAREERS

Senior Project Manager

CAI

Boston, MA, USA

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Tony Coles, Cerevel CEO

August 11, 2022 07:26 AM EDTUpdated 09:13 AM

Financing

Cerevel takes the public offering route, with a twist — raising big money thanks to rival data

Max Gelman

Senior Editor

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Tony Coles, Cerevel CEO

August 12, 2022 09:11 AM EDTUpdated 09:25 AM

Financing

Bioregnum

Cerevel's Tony Coles is still counting his money as a rival's boost helps fuel a potential $609M windfall

These days in biotech, you never want to miss a chance to raise money for public companies. As much money as possible.

That survival strategy was in full view over the last 24 hours as Cerevel $CERE announced a major stock/debt raise, then upped the ante with a bigger debt load than initially planned.

The tally: $238 million – net — with a shot at boosting that to $274 million from the stock sale, provided the underwriters come back for more. And there’s $335 million from the debt, provided their first round buyers come back for an added bite. Rounding up, that’s $609 million with the add-on. Even without the add-ons, though, it’s still $530 million in the bank.

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