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Policy & Regulation

Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns

Restrictions placed on the use of Gedeon Richter’s uterine fibroid drug Esmya by the European Medicines Agency could significantly dent the product’s sales in the EU, and could also have a knock-on effect in the US, where the FDA accepted an NDA filing for the drug in October 2017.

Drug Safety Drug Review Europe

US FDA Advisory Cmte. Review Of Charleston's Hydexor Exposes Flaws In Commercial Strategy

Physicians may be hesitant to prescribe the opioid/anti-emetic combo for several reasons; panelists were concerned the company hasn't figured out a specific commercial audience for Hydexor at this point in the review process.
Advisory Committees Neurology Regulation
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Policy

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FDA Deputy On CRLs: 'It's Not Our Property To Release'

US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.

FDA Complete Response Letters

Mehta Analysis: How Buffett And Friends Can Succeed, And How Pharma Would Be Affected

How Warren Buffett's company Berkshire Hathaway, Amazon and JPMorgan will address the challenge of creating affordable, quality healthcare for their employees in the US is far from clear, but they are intent on trying. Viren Mehta, founding partner of Mehta Partners LLC, considers what approach they might take to succeed where others have failed, and how such a course would impact on the pharma sector.

Private Payers Healthcare Systems

What ‘Modicare’ May Mean (Or Not) For Pharma In India

Ambitious and complex to say the least, India’s “Modicare” – the proposed National Health Protection Scheme – could have significant implications on market expansion in the country. Scrip brings you an early take from pharma industry experts on what to expect (or not) and where the key challenges lie.

Policy & Regulation Policy

New Report Calls For Pushing And Pulling In Global Fight Against Superbugs

New DRIVE-AB report on revitalizing antibiotic R&D suggests market-entry rewards of up to $1bn for companies introducing novel products, cites need for increasing public funding of R&D support.

Infectious Diseases Research & Development

J&J Shows Grace Under Pressure From Biosimilars And Other Threats

Oncology stars Darzalex and Imbruvica lift a strong fourth quarter, but Remicade biosimilars and pricing discounts continue to threaten to take a bite out of future performance. Tax reform and Amazon's potential entry into healthcare could also affect the diversified firm.

Sales & Earnings Business Strategies

PTAB Clears Path For Earlier Generic Zytiga Launch

Patent Trial and Appeal Board finds that the patent covering the blockbuster prostate cancer drug is unpatentable, which could allow generics to launch at-risk in October once they obtain FDA approval; at least 12 firms have pending ANDAs.

Policy Intellectual Property
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Regulation

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Latest From Regulation

Bristol Debuts Opdivo/Yervoy Data In New First-Line Lung Cancer Bid

The pharma hopes showing a PFS benefit in first-line NSCLC patients with a high tumor mutation burden may provide a way to compete with Merck in that setting, but analysts think it will need overall survival data.

ImmunoOncology Cancer

Santhera Braced For Another CHMP No In Duchenne

Santhera had a tumultuous 2017 and recovery is not going to be easy this year as its lead compound for the rare disease Duchenne muscular dystrophy is about to be rejected by regulators in Europe for a second time.

Rare Diseases Policy & Regulation

Oral Testosterone Therapies Face Clinical Practice Difficulties, Advisory Panels Suggest

FDA's advisory committee voted down Lipocine's Tlando and Clarus' Jatenzo based on concerns about off-label use, but if they do reach the market, Tlando's lack of titration could pose problems for physicians, while both drugs could raise difficulties with the types of tubing used to test testosterone concentrations.

Advisory Committees Regulation

A Year To Remember For US Drug Launches

A record-breaking 46 novel drugs and biologics were approved by FDA in 2017. The number of drugs that launched were plentiful and several were highly innovative, ushering in a new era of therapeutic breakthroughs. Turning pioneering medicines into commercial successes will be the test.

Launches Approvals

Spark's Luxturna Approval Ushers In A New Gene Therapy Era

Spark's gene therapy for patients with an inherited form of blindness will be available in the US late in the first quarter, but on the big question – whether it will cost $1m for the one-time treatment – Spark would not say.

Approvals Rare Diseases

Novartis Stockpiling Priority Review Vouchers

Firm picks up second PRV with purchase from Ultragenyx, which is expected to use the $130m to help advance its rare disease development pipeline.

Business Strategies Drug Review
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