Novartis is ‘all in’ on siRNA, inking a new collaboration with Alnylam to develop alternative to liver transplants

Jay Bradner, NIBR president (Jeff Rumans)

January 6, 2022 11:14 AM EST

Novartis is 'all in' on siRNA, inking a new collaboration with Alnylam to develop alternative to liver transplants

Nicole DeFeudis

Editor

Alnylam was a few years ahead in the small interfering RNA (siRNA) space when Novartis jumped on the bandwagon in early 2020, licensing the company’s cholesterol-lowering drug Leqvio through its buyout of The Medicines Company. Less than a month after securing an approval, the pharma giant wants more where that came from.

Novartis is joining forces with Alnylam once again for the discovery and development of a regenerative siRNA-based therapy to treat end-stage liver disease, the companies announced on Thursday.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

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 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.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

August 12, 2022 02:02 PM EDT

Pharma

Law

Senate Finance Chair continues his investigation into pharma taxes with requests for Amgen

Zachary Brennan

Senior Editor

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

ENDPOINTS CAREERS

Chief Scientific Officer

Experimental Drug Development Centre

Singapore

view job offer post your job now

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

August 12, 2022 02:11 PM EDT

Pharma

Marketing

Do pharma TV and social ads work? Pharma marketing agencies adopting new tech solutions to find out

Beth Snyder Bulik

Senior Editor

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Corey McCann, Pear Therapeutics CEO

August 12, 2022 02:09 PM EDT

Pharma

Pear Therapeutics touts Q2 growth while scaling back full-year goals and chopping 9% of staff

Nicole DeFeudis

Editor

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

August 12, 2022 01:51 PM EDTUpdated 02:14 PM

Pharma

Law

Paving the way for Merck's buyout, Seagen loses arbitration dispute with Daiichi over ADC tech

Zachary Brennan

Senior Editor

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

August 12, 2022 12:47 PM EDTUpdated 02:10 PM

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.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Senior Project Manager

CAI

Boston, MA, USA

view job offer post your job now

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.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.