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Set Alert for Manufacturing

Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

Manufacturing Reimbursement

WHO Launches Twin-Track Procedure To Speed Access To Health Products

A procedure used to accelerate the approval of COVID-19 products during the pandemic is to be applied to all medicines using “synchronized and parallel, but otherwise entirely independent, processes,” the World Health Organization says.

International Market Access

Germany Promises Harmonized ATMP Rules & More Flexibility For Decentralized Trials

Industry is wary of a provision in Germany’s medical research bill that would introduce standard clauses in the contracts agreed between trial sponsors and study sites.

Europe Germany

When Using Artificial Intelligence In Pharma R&D, Start With Identifying Problem To Solve

VeriSIM uses generative AI for questions such as changing a drug molecule’s chemistry and machine learning to better predict potential biological implications, says CEO Jo Varshney.

Artificial Intelligence Research & Development

BeiGene’s Tevimbra And The End Of The COVID Inspection Era

US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

US FDA Performance Tracker Approvals

Risks For Pharma Industry Remain As BIO Shifts Course On BIOSECURE Act

Trade group’s break from WuXi Apptec allows BIO to reset its lobbying approach under its new CEO but doesn’t negate the business and supply chain disruptions that biopharma would feel from the proposed legislation.

Lobbying Legislation

China Biotech Hopes Innovation Wins The Day As Legislative Attacks In US Congress Increase

The latest development shows that BIOSECURE Act is gaining momentum in the US Congress and off Capitol Hill. In the meanwhile, the Chinese biotech sector embraces uncertainty but hopes that common interests in health innovation will prevail in the end.

Legislation Supply Chain

US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find manufacturer of contaminated eye drops that disappeared.

Supply Chain Quality

US FDA Looks To Re-Establish African Foreign Office, Add Brazil Post

As Congress pressures FDA to increase foreign inspections, the agency unveils plans to strengthen its overseas presence, including new offices and more staff in the New Delhi, India, post. Deputy Commissioner Kimberlee Trzeciak notes the moves are resource dependent.

Manufacturing Clinical Trials

US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks

The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.

Drug Approval Standards Quality

US FDA's Cruse Outlines Paths To Quicker Inspections

As US pharmaceutical inspectorate advances toward its pre-pandemic inspection cadence, there is a new focus on accelerating the site inspection process, as well as an effort to improve retention with quicker, more targeted training. OPQO chief Alonza Cruse reviews key ideas at GMP conference.

Manufacturing Quality

Mark Cuban: Pharma’s Secret Weapon In The Fight Against PBMs

The well-known businessman and TV personality told the White House that the US needs to ‘stop doing business with the big three PBMs,’ helping to fight the drug industry’s battle against the middlemen with a friendlier face not associated directly with the brand industry.

PBMs Pricing Debate

Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods

As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures, which applicants for drug approvals and biologics licenses could use to reduce method validation requirements. Pfizer undertook the first commercial application of the platform analytical approach, which is widely used in development.

Drug Approval Standards Quality

Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections

Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances. 

Australia Manufacturing

US Toning Down China CDMO Tension But New Restrictions Emerge

The latest developments in a US Congressional draft bill to curb Chinese biotech operations in the US is separating contract manufacturing and research from gene sequencing service providers, which may give China's major contract players reasons to breathe easy. 

China United States

Singapore & South Korea’s Recognition Of GMP Inspections To Cut Burden For Companies

A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.

Singapore South Korea
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