East Brunswick, N.J.-based generic drug manufacturer Rising Pharmaceuticals agreed to pay about $3 million in fines and restitution and to cooperate with an ongoing criminal investigation after being charged with price fixing. The company admitted to conspiring with a rival manufacturer on pricing benazepril HCTZ, a blood pressure drug, between April 2014 and at least September 2015, US Attorney William McSwain said.

Three pharmacy chains are suing Bausch Health, its subsidiaries and a generic-drug maker for allegedly colluding to prevent market entry of a generic version of Glumetza, enabling the companies to raise the drug's price from $350 to more than $3,000 for a 30-day supply.

A 2017 cyberattack on Merck shut down production for weeks, causing $1.3 billion in damage and leading to litigation when most of Merck's 30 insurers and reinsurers denied coverage. This in-depth look at the attack and its aftermath explores how the dispute, in which the insurers claim the Russia-linked attack constituted an act of war, could have far-reaching consequences for companies and insurers.

Off-the-shelf gene therapies are now considered the next big thing in treatments for leukemias and lymphomas due to the speed with which they can be produced compared with chimeric antigen receptor T-cell treatments, which often take two weeks to produce, a period of time that could see the patient it is intended for deteriorate or even die. One example of such a treatment discussed at the annual meeting of the American Society of Hematology was Fate Therapeutics' off-the-shelf CAR NK cell therapy, the first-of-its-kind treatment that targets multiple antigens.

Makers of some Class I medical devices and software could get an additional four years to come into compliance with the European Union's Medical Device Regulation, under amendments proposed in the Council of the European Union's second corrigendum. The amendments would need to be formally adopted by the European Parliament before taking effect.

The FDA has finalized its guidance on adaptive clinical trial designs for drugs and biologics and the information the agency will review from the submission as part of new drug applications, investigational new drug applications, biologics license applications and supplemental submissions. The guidance cleared the recommendations for Bayesian adaptive designs and the expectations for the extent of prespecification necessary for adaptations to studies.

Astellas Pharma of Japan announced it plans to purchase gene therapy developer Audentes Therapeutics in a $3 billion all-cash deal. Audentes is developing AT132, an investigational therapy to treat X-linked myotubular myopathy that causes severe muscle weakness.

The acquisition provides Aon with additional access to the fast-growing, $200-plus billion premium digital insurance market for small and medium-sized businesses, as well as the opportunity to leverage CoverWallet's platform to develop and scale innovative digital client experiences that support the firm's Aon United growth strategy. "We are excited to combine Aon's expertise in data and analytics and global distribution with CoverWallet's market-defining platform to create new sources of value for our clients," said Greg Case, CEO of Aon. "CoverWallet's culture of innovation is transforming the insurance landscape, and together we have the opportunity to further strengthen and expand the application of their digital client experience." Learn more.