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Policy & Regulation

New National Security Checks Could Hinder Investment, Warns UK Biotech Sector

Life science SMEs and their investors need to comply with new UK government checks on their dealmaking.

Companies Commercial Regulation

Novo Nordisk On The Pluses And Minuses Of The UK Post-Brexit R&D Environment

Post-Brexit Britain offers a fertile R&D ecosystem, but it needs to improve uptake in novel medicines there and strike a lasting deal with the EU over batch testing, Novo Nordisk’s UK general manager Pinder Sahota tells Scrip.

Brexit Clinical Trials Companies

Policy

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Patent Settlements and Medicare Negotiation: What Leverage Does Pharma Have To ‘Game’ Price Reform?

Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

Legislation Pricing Debate

Korean Biopharma Today And Tomorrow: M&A, Investment, Governance

Experts shared views at a recent conference in Seoul on how the Korean biopharma industry has evolved and what needs to be done to move forward in the next 10 years. Policy efficiency and family ownership in the sector came in for particular scrutiny, with some calling for sweeping changes. 

South Korea M & A

Don’t Look Up? Investors Call For Tweaks To Small Molecule Provisions In US Pricing Bill

Investors and pharma stakeholders scramble to extend the time period before small molecule drugs are subject to government mandated discounts as Senate drug pricing legislation moves toward a floor vote.

Pricing Debate Legislation

China-US Tensions Rise Sharply On Pelosi Visit, Will Biotech Get Burned?

Where once there were promising prospects for cross-strait collaboration, biopharma firms in mainland China and Taiwan may now find themselves looking elsewhere for partners following a controversial visit to Taipei by US House Speaker Nancy Pelosi.

China Policy

Pharma Braces For Potential Landmark Moment For US Drug Price Controls

US drug pricing legislation that has picked up momentum could stymie R&D investment and curb the revenue tail for some big drugs, industry says, but CEOs also expect they can navigate the challenge. 

Legislation Pricing Debate

From Decoupling To Delisting: Might Biden-Xi Talks Ease Biotech Overhang?

While a two-hour-plus online discussion between the leaders of the world's two largest economies had some encouraging signs for the biopharma sector, more remains to be done and multiple other factors are playing into a mix of decoupling pressures.

China United States
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Regulation

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Latest From Regulation

Maureen Kenny, 1963-2022

Kenny, a mainstay of our publications for three decades, has passed away in London.

Regulation BioPharmaceutical

Sarepta Pursues DMD Gene Therapy Accelerated Approval To Be First To Market

Sarepta has experience pursuing accelerated approvals in the US for Duchenne muscular dystrophy therapies, but with a costly gene therapy will payers require data from a controlled Phase III study?

Gene Therapy Reimbursement

AstraZeneca’s Triple Regulatory Wins For Enhertu, Tezspire And Ultomiris Herald Sales Boost

The major has won US priority review for a commercially crucial label expansion of its breast cancer drug Enhertu while Tezspire and Ultomiris attracted positive CHMP opinions across the Atlantic.

Companies Approvals

Valneva's COVID-19 Vaccine Hopes Almost Over Before They Start

Rather than terminating a deal for the French biotech's VLA2001 vaccine, the European Commission has put in a tiny order of 1.25 million doses which could bring the curtain down on Valneva's COVID-19 programs.

Coronavirus COVID-19 Vaccines

Novavax’s COVID-19 Shot Finally Authorized In US, But Could Miss Out Again On Bivalent Booster

A protein-based vaccine for COVID-19 reaches the US at last, but Novavax looks set miss out once again as the fall deadline for BA.4/5 variant-targeting vaccines approaches.

Coronavirus COVID-19 Approvals

HHS Price Negotiations Could Be Delayed When Biologics Have Biosimilars Pending Under Bill

Latest iteration of drug pricing legislation from Senate Democrats would also firm up the number of drugs HHS must choose for price negotiation each year and no longer treats insulin as a separate class for purposes of negotiation.

Pricing Debate Medicare
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