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US FDA's Drug Shortage Effort Questioned By GAO

GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.

FDA Life Cycle Management Regulation

Amgen Can't Stop Avastin Biosimilar 'Patent Dance' After Opting In, Genentech Says

Genentech seeks court order requiring Amgen to provide biosimilar manufacturing info so it can evaluate potential infringement; Supreme Court to hear Zarxio case on April 26.

BioPharmaceutical Policy Biosimilars

Canada Attempts Biosimilar Balancing Act

Plans to make Canada’s biologics market more competitive for biosimilars are advancing as payers are planning consultations on how price negotiations for biosimilars and biologics will proceed.

Biosimilars Policy Canada

Turkey Grapples With Spinraza Cost As Patients Seek Access

Families of spinal muscular atrophy patients in Turkey are demanding immediate access to Biogen’s Spinraza following its US approval in December. Its public payer is in discussions over possible reimbursement of the high-priced imported drug but the company is said to have shown no pricing flexibility so far.

Turkey Pricing Debate Policy

FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Keeping Track: US FDA Approves Siliq, Accepts Mylan/Biocon Pegfilgrastim Biosimilar

The latest drug development news and highlights from our FDA Performance Tracker.

Performance Tracker Approvals Regulation

Latest From Regulation

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Regulation Clinical Trials

Feel The Quality: Biosimilars Dominate Standards Setting Debate In EU

The quality issues that the European Medicines Agency considers when it evaluates biosimilar medicines became clearer during a recent event held in Strasbourg, France, where delegates also learned more about the role of European Pharmacopoeia monographs in ensuring the quality of biosimilars.

Biosimilars Quality

Sandoz Tested Erelzi’s Suffix On Multiple Fronts

Evaluations of potential nonproprietary name suffixes for the US biosimilar to Amgen’s Enbrel included checks on Internet search engines and databases of abbreviations and proprietary names, as well as safety, trademark and phonetic analyses.

Drug Review Profile Biosimilars

Latest From Policy

Medicaid Drug Rebates Will Get Closer Scrutiny From CMS, Verma Pledges

CMS Administrator-nominee Seema Verma promises stronger agency oversight of Medicaid drug rebate program in response to question from Sen. Grassley during Senate confirmation hearing.

Policy Medicaid

Judge Gorsuch Could Be Pharma Ally In FDA Disputes

Supreme Court nominee's opposition to deference for administrative agencies could help biopharma industry in its battle over off-label communications if the issue ever goes before the court; he also supports securities litigation reform.

BioPharmaceutical Policy

US Medicaid Reform: Legislators Caution CMS Nominee About Coverage Loss

Seema Verma is closely identified with Medicaid reform but both Republicans and Democrats expressed concern during her Senate confirmation hearing that reforms not translate into loss of insurance coverage.

Policy Medicaid

Clinical / R&D Explore this Topic

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Latest From Research & Development

Intercept's Revised NASH Trial Improves Prospects

The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

Clinical Trials Research & Development

Catabasis Refutes MRI T2 Biomarker In Duchenne Study

Catabasis says biomarker MRI T2 doesn't work after all in boys with Duchenne's, plans to stick with four-step climb test or 10-meter walk/run test from now on.

Clinical Trials Research & Development

Small Biopharmas Should Be Wary Of Early Results – US FDA Official

Two former Genzyme execs, one of whom now works at CDER, warn small companies to avoid over-emphasizing results from early, uncontrolled trials in their planning and business decision-making.

Research & Development Clinical Trials

Commercial Explore this Topic

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Latest From Commercial

J&J Outlines Pricing Transparency Plan, Will Others Follow?

CEO Gorsky describes J&J’s approach to drug pricing and pledges to provide more detail in an annual transparency report. Investor pressure regarding the pricing debate continued during the Novartis earnings call. Value arguments expected to dominate pharma’s message.

Pricing Debate Sales & Earnings

New Policy Fund Reflects Korea’s Commitment To Health Biotech

South Korea's plan to create a policy fund to support new growth engine industries seems to reaffirm the government's unwavering commitment to nurture the biotech and health care sectors despite the ongoing political chaos in the country.

South Korea Financing

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

Manufacturing Explore this Topic

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Latest From Manufacturing

Biotech Firms Struggle To Replicate Analytical Methods For Commercial Use

The process of transferring analytical methods from research labs to commercial labs is fraught with challenges and biotech manufacturers must pay careful attention to everything in the transfer process, especially for overseas transfers. A diverse toolkit is needed to test these complex molecules. An increasing number of product launches is putting pressure on biotech manufacturers to complete these tech transfers quickly, and industry is receiving little guidance from FDA.

Biologics Manufacturing

BMS Label Issue Adds To China Drug Shortage Woes

While shortages of some drugs in China are not new, a recent case of a patient scrambling to locate a potentially life-saving chemotherapy to complete their treatment has shone new light on the problem, which the government is taking various steps to combat.

Manufacturing Cancer

Enforcement In Brief: Key Points In Recent FDA Warning Letters And EU GMP Noncompliance Notices

Particulates, sterility failures and basic GMP noncompliance loomed large in FDA warning letters and EU GMP noncompliance notices to Facta Farmaceutici, Porton Biopharma, Antibioticos do Brasil, Euro Far, Ningbo Zhixin Bird Clean-Care, CTX Lifesciences and Pharmco Laboratories posted online last month.

Compliance Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Ipsen's Latest Consumer Health Play: Growth Or Attracting Suitors?

Less than a month after investing in Italian nutritional supplement maker Akkadeas Pharma, Ipsen acquires five Sanofi OTC drug brands marketed in Europe, including Prontalgine analgesics available in France.

Consumer M & A

Reckitt Expands 'OTC' Business, China Presence With Mead Johnson

Marketing Enfamil and other Mead Johnson formula and nutritional brands, says RB CEO Rakesh Kapoor, is "very much in the core of what consumer health stands for," and also immediately doubles the size of the firm's consumer business.

Consumer China

Consumer Health Weekly Trademark Review Feb. 7, 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

Trademarks Consumer