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Puma’s Neratinib Brings Uncertain Efficacy, Tolerability Concerns To FDA Panel

Tyrosine kinase inhibitor has an effect in adjuvant breast cancer but ‘there remains some uncertainty regarding the true magnitude of the treatment effect,” FDA reviewers say; given incidence and severity of diarrhea, experts will be asked to consider whether there is a subpopulation with a more favorable risk/benefit profile.

Advisory Committees Drug Review Regulation

Emmaus Needs US FDA Advisory Cmte. To Rescue Sickle Cell Disease Candidate

FDA reviewers disagree with Emmaus' extrapolation methods for holes in efficacy data for its L-glutamine ahead of May 24 Oncologic Drugs Advisory Committee meeting.

Advisory Committees Clinical Trials Regulation

Biopharma Patent Disputes: Upheaval Likely As US Supreme Court Limits Litigation Venue

Decision requiring suits to be filed in state where defendant is incorporated may deter consolidation of ANDA suits and increase venue fights; Court to hear challenge to PTAB inter partes review process.

Intellectual Property BioPharmaceutical Policy

US FDA Urged To Rethink Warning Letters To Avoid ‘Collateral Damage’

Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance

Compliance Manufacturing Quality
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Policy & Regulation Explore this Topic

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Woodcock Wants Rapid Regulatory Policy Development

CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.

FDA Regulation Biosimilars

Latest From Regulation

AB Science Asks For Re-examination After EMA Rejects Masitinib For Mastocytosis

The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.

Drug Review Compliance

Amgen Migraine Antibody, Bayer Oncologic, Spark Gene Therapy Join NME Review Queue

US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.

Approvals Drug Review

Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

Keeping track of US FDA approvals last week included watching the creative and the familiar.

Approvals Review Pathway

Latest From Policy

Foreign Pharma Takes Simmering Price Concerns To New Korea Govt

Amid an escalating tussle with the health ministry over the level of South Korean drug prices, foreign pharma firms operating in the country are now proposing the launch of a new joint study on the issue with the incoming government.

South Korea Pricing Debate

Biosimilar Litigation: Janssen Vs. Samsung Anticipates Supreme Court Decision

Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.

Biosimilars Legal Issues

Coherus Knocks Out One Humira Patent But Others Block Biosimilars

Patent Trial and Appeal Board invalidates patent on method to treat rheumatoid arthritis; next hurdle is overcoming formulation patents that do not expire until 2022.

Biosimilars Intellectual Property

Clinical / R&D Explore this Topic

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Latest From Research & Development

Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU

The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.

Research & Development Regulation

RSV Vaccines Need Multiple Animal Models Before Infant Testing, Panel Says

US FDA's advisors want data from three animal models – not just the cotton rats that Janssen was hoping for – before candidate vaccines are tested in healthy infants.

Advisory Committees Vaccines

FDA Should Let Alzheimer’s Trials Rely On Single Endpoint, Group Says

Informally, FDA appears open to trials that use cognition as the only primary endpoint rather than insisting that products also show benefit on the functional side.

Drug Approval Standards Neurology

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Latest From Commercial

Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

Robert Califf Talks Verily, Hopes Gottlieb Can Push Back On Trump

Former US FDA Commissioner is joining the health-technology firm Verily, a Google spin off. In a podcast interview he discusses his new advisory role with the company and expresses his hope that new FDA Commissioner Scott Gottlieb would stand up to any 'whimsical directives' from President Trump.

FDA Legislation

Amgen's Repatha Contract With Harvard Pilgrim Includes A Full Refund

Harvard Pilgrim Chief Medical Officer Michael Sherman said the full warranty behind the agreement is the right kind of deal to balance access and cost.

Reimbursement Pricing Strategies

Manufacturing Explore this Topic

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Latest From Manufacturing

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Manufacturing Regulatory Updates In Brief

FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.

Quality Manufacturing

Manufacturers' Data Integrity Problems Remain FDA Investigators' Focus

US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

Consumer Legislation
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