CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.

Recent incidents of illness and death caused by contaminated cough syrups show that there is a need to review the “member state mechanism” that is intended to coordinate efforts to tackle poor quality medical products, the World Health Organization says.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.

The UK government has set aside dedicated funds to deliver ambitious changes that would make it quicker and easier for companies to trial more of their products in the National Health Service. 

Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.

A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.

Japan will end full reimbursement coverage for COVID-19 therapeutic drugs from October, after downgrading the status of the virus to the same level as seasonal flu in early May. As authorities discuss the possible coverage reduction, a larger than usual price cut may also be applied to Shionogi's oral COVID antiviral Xocova.

Commissioner expresses concern about agency lawyers leaving and then representing US FDA’s opponents in court. Also, as lawsuits about abortion pill continue, KFF finds the public trusts FDA more than the judiciary on determining products’ safety and effectiveness.

CMS proposed rule impact may be ‘modest’ but is framed as ensuring patient access to cutting edge treatments by helping to control Medicaid spending. Biden administration initiative also aims to address misclassification of brand drugs, duplicative 340B discounts, and PBM spread pricing.

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Leaders from Novartis, IQVIA and PwC discuss the ground situation for trials in India as regulatory reforms, improved infrastructure and clinical expertise provide opportunities. Potential in areas like orphan diseases and tips for peer Amgen on getting trials going in India were among other highlights.

Pfizer chief clinical officer William Pao, Roche pharma CEO Teresa Graham and others weighed in on what FTC’s action could mean for pharma M&A at the Financial Times Pharma Summit.

The company has been found in breach of the UK code once again for its work with pharmacists,  although this time Novo Nordisk has escaped the heaviest censure.

Leonard Schleifer said it is time for US regulators to review whether certain rebate practices are anti-competitive, while speaking at the Financial Times US Pharma & Biotech Summit in response to the FTC’s effort to stop Amgen’s acquisition of Horizon.

FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.

The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.

Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.