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Biological Product Suffix Submissions Limited To 10 Candidates By US FDA

Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.

Regulation Biosimilars Biologics

UK QPPVs Fear Brexit Could Seriously Threaten Their Role In Pharmacovigilance

UK based QPPVs are worried about the direct and tangible impact of Brexit on their current jobs, fearing that the QPPV role may either completely vanish from the UK or have its authority undermined.

Regulation Europe United Kingdom

India’s Trial Approval Timelines Report Card – Some Red Lines?

India’s streamlined clinical trial approvals process appears to have made some gains, but top industry experts tell Pink Sheet how the non-standardized approach of Subject Expert Committees is a “major handicap” for applicants.

Regulation Clinical Trials India

ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit

Generics must be able to be administered without provider intervention or patient retraining, draft guidance says.

Combination Products Generic Drugs Regulation
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Policy & Regulation Explore this Topic

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EMA And National Agency Heads Join Forces On Medicines Availability and Big Data

The European Medicines Agency and the EU Heads of Medicines Agencies network are working together on a broad range of subjects, from big data to the availability of medicines… and of course, Brexit.

BioPharmaceutical Distribution Brexit

Latest From Regulation

BIA Says NHS Funding Changes Would Jeopardize Life Science Sector, As UK PM Announces ‘Hard’ Brexit

As prime minister Theresa May confirms that the UK is to leave the EU single market, the BioIndustry Association has warned that proposals by NICE and NHS England to change funding arrangements for innovative drugs risks impairing the competitiveness of the UK life sciences sector.

United Kingdom Market Access

India Drug Watchdog Says 4-5% Of Drugs Still Substandard

Health authorities have been working for years toward ensuring the safety of medicines in the global supply chain, and India - one of the biggest providers of inexpensive generics worldwide - has been a key focus. But while the incidence of substandard medicines in the country has fallen, it still hovers at around 4-5% of supplies, according to the country’s drug regulator, which is proposing new steps.

India Regulation

FDA New Year’s Resolution: Guidances On Payor Communications, Biosimilarity

Agency expects to issue 101 guidances in 2017, including those on REMS assessment, refusal to file NDA and BLA submissions, and amendments to ANDAs.

BioPharmaceutical Regulation

Latest From Policy

BIA Says NHS Funding Changes Would Jeopardize Life Science Sector, As UK PM Announces ‘Hard’ Brexit

As prime minister Theresa May confirms that the UK is to leave the EU single market, the BioIndustry Association has warned that proposals by NICE and NHS England to change funding arrangements for innovative drugs risks impairing the competitiveness of the UK life sciences sector.

United Kingdom Market Access

Indian Teen’s Fight For Lifesaving TB Drug Highlights Access Issues

An Indian teenager’s court battle for a new tuberculosis drug that doctors say could save her life has cast a harsh spotlight on the slow rollout of breakthrough medicines to treat the disease in the country, one of the world’s biggest TB hotspots.

India Policy

Price Rebates Will Continue As ‘Fact Of Life’ In Drug Contracting

Pharmacy benefit managers will continue to collect rebates from manufacturers in return for market share even though the practice is being challenged by drug pricing critics, Avalere’s Mendelson predicts.

Pricing Debate Market Access

Clinical / R&D Explore this Topic

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Latest From Research & Development

Top 16 From '16: Pink Sheet's Most Popular Stories

Big developments, key biopharma trends, and other topics that most intrigued and impacted our readers in 2016.

Policy Research & Development

Wellcome Trust Makes AMR Strategic Priority After Funding O'Neill Review

Britain's well-endowed and influential Wellcome Trust which co-funded the O'Neill Review on how to tackle antimicrobial resistance has now made AMR one of its strategic priorities and aims to raise its profile with it. Wellcome policy head Ed Whiting outlines next steps in an interview with the Pink Sheet.

Infectious Diseases Research & Development

Agios Heads Toward Pivotal Study As FDA Places Hold On Backup

Biotech’s decision on which candidate to advance to pivotal studies in pyruvate-kinase R deficiency is clarified as backup candidate AG-519 is placed on clinical hold and shelved. Agios hopes to bring the first disease-modifying PKD drug therapy to market.

Clinical Trials Drug Safety

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Latest From Commercial

UK’s NICE Reverses View On Afinitor In Renal Cancer After Novartis Cuts Price

UK HTA body NICE says it is now backing Novartis’s Afinitor for the treatment of some people with advanced kidney cancer on the publicly funded National Health Service after the Swiss group offered a price discount. This changes the availability in England and Wales of the drug, which was previously only available through the controversial Cancer Drugs Fund. NICE has now given the go-ahead for routine commissioning of 13 cancer drugs/indications that were listed on the CDF before it was revamped last year.

Health Technology Assessment Cancer

J.P. Morgan Notebook Day 3: Novartis' Cancer Reorg, AbbVie's Price Pledge, Genentech’s Partnering And More

Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco: Comments from President-elect Donald Trump hovered over the crowd, but companies aimed to stay focused on moving forward regardless of what policy changes are coming.

Commercial Companies

J.P. Morgan Notebook Day 2: Bristol Humbled By Competition, Sanofi’s Sarilumab Ready For Review, Justifying Spinraza’s Price And More

Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco. Bristol-Myers CEO humbled by PD-1 competition in lung cancer; Sanofi’s sarilumab manufacturing issues resolved; Biogen, Ionis discuss SMA drug’s high cost; Shire happy with Xiidra launch to date; Sarepta says more than 250 patients have started Exondys treatment; J&J’s Gorsky on innovation and pricing; and Amicus reveals US approval strategy for migalastat.

Commercial Companies

Manufacturing Explore this Topic

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Latest From Manufacturing

India Drug Watchdog Says 4-5% Of Drugs Still Substandard

Health authorities have been working for years toward ensuring the safety of medicines in the global supply chain, and India - one of the biggest providers of inexpensive generics worldwide - has been a key focus. But while the incidence of substandard medicines in the country has fallen, it still hovers at around 4-5% of supplies, according to the country’s drug regulator, which is proposing new steps.

India Regulation

Manufacturers Urged To Prevent Drug Shortages By Reducing Quality Risks

As the main cause of drug shortages is poor manufacturing quality, the best way to prevent them is to get ahead of the curve on quality, says a Pew/ISPE industry survey report.

Quality Manufacturing

US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing

Tesaro’s IV formulation of Varubi draws letter keeping with last year’s emerging trend of manufacturing-related CRLs, in this case agency concerns about CMC data related to comparability of drug produced by two different contractors; issue seems unlikely to significantly delay approval of the new version of CINV drug, however.

Complete Response Letters Manufacturing

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Latest From Consumer

Weekly Trademark Review Jan. 10, 2017

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Australia China

Guidance On Acetaminophen Allergy Warning Trails Industry's Change

Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.

United States Consumer

Aspirin Wearing Hearts On Packages Needs CV Statement, Too – CDER

In a draft US guidance, CDER encourages firms marketing OTC aspirin products with "cardiovascular-related imagery" on packaging to add a statement reminding consumers to talk to their health care providers before using aspirin for secondary prevention of CV events.

Consumer Drug Safety
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