Apple Watches violate AliveCor patents, ITC rules

Today's Big News

Jan 3, 2023

Biden signs $1.7T omnibus, paving way for multiple health policy priorities


Merck KGaA hands over IL-12-targeting cancer med to PDS Biotech in $121M deal


2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37


ECG-equipped Apple Watches found to violate AliveCor patents, teeing up possible sales ban


Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

 

Featured

Biden signs $1.7T omnibus, paving way for multiple health policy priorities

Just ahead of the year-end deadline, President Joe Biden signed into law a massive $1.7 trillion spending package that includes a slew of healthcare policy priorities.
 

Top Stories

Merck KGaA hands over IL-12-targeting cancer med to PDS Biotech in $121M deal

Merck KGaA is continuing its recent run of dealmaking, handing over an IL-12-targeting cancer med to PDS Biotech in a deal worth more than $120 million. The med is being tested as part of a triple combo therapy that also includes PDS Biotech's lead immunotherapy asset.

2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37

Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. In 2022, however, fewer drugs were approved than was typical in recent years. Is this the result of the FDA becoming gun-shy after its much-criticized sanction of Biogen's Alzheimer's disease treatment, Aduhelm, in 2021? Or was 2022 just a cyclical blip on the approval landscape?

ECG-equipped Apple Watches found to violate AliveCor patents, teeing up possible sales ban

Right after a major win for Apple in its patent dispute with fellow wearable device maker AliveCor, the tech giant has hit a roadblock.

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

A scathing congressional report has detailed communications described as "inappropriate" and "atypical" between Biogen and the FDA regarding the approval of Alzheimer’s disease drug Aduhelm plus the decision-making behind the pricing and marketing of the now-benched medicine.

Gilead hopes to evoke ideas for new autoimmune treatments with $659M deal

Gilead plans to work with EVOQ Therapeutics to hopefully bring to mind new treatments for autoimmune disorders in a deal worth up to $658.5 million.

ReCor Medical taps Siemens alum as CEO amid FDA review of renal denervation system

New year, new CEO. That’s the 2023 mantra for ReCor Medical, which kicked off the year with the appointment of a new leader.

LCMC Health finalizes Tulane University hospital purchases with regulator's blessing

First announced in October, the deal brings Tulane Medical Center, Lakeview Regional Medical Center and Tulane Lakeside Hospital under the nonprofit system's belt. The purchase had been opposed by a major nurses' union.

Weak data as booster for Comirnaty close off opportunity for Valneva's COVID-19 vaccine

Valneva’s plans to establish its COVID-19 vaccine as a booster to Pfizer and BioNTech’s Comirnaty have taken a blow, with a clinical trial of the shot eliciting “only a marginally increased neutralizing antibody response.”

Novartis pays $245M to settle Exforge generic pay-for-delay lawsuit

Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements. The lawsuit centered on an agreement Novartis and Endo's Par signed in 2011 that allegedly pushed back the launch of a copycat to Novartis' Exforge.

Minerva Surgical taps outgoing Activ Surgical head Usen for CEO

The growing list of medtech CEO switch-ups is beginning to resemble a game of musical chairs—and one experienced leader just found a new seat.

ACA exchange enrollment continues at record pace, nears 11.5M through mid-December

Sign-ups on the Affordable Care Act's exchanges continue at a record pace, according to new data from the Biden administration.

First startup blooms from Mayo Clinic cell and gene therapy accelerator with $750M Cellectis partnership

Seeds from Mayo Clinic’s cell and gene therapy accelerator Mayflower Bioventures have taken flight in a new biotech called Primera Therapeutics, which launches today with a blossoming $750 million partnership to work on therapies for mitochondrial diseases.
 
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'Podnosis': 2022's digital health unicorns and tapping population health for better care delivery

This week on "Podnosis," we talk about this year's class of digital health companies that crossed the $1 billion valuation despite an overall funding slowdown. We also discuss how best to leverage population health management to improve how care is delivered and make it more holistic.
 

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