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Novartis wins CHMP nod for cancer drug combo

Novartis’ drugs Tafinlar and Mekinist edged closer to approval in Europe to be used together against a type of lung cancer.

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Novartis cancer drug Zykadia gets FDA priority review

The U.S. Food and Drug Administration (FDA) has granted priority review to the Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said.

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First-Ever Device for Fast and Virtually Painless Blood Draw Receives FDA Clearance

Seventh Sense Biosystems Inc. (7SBio) announced that a new blood collection device called TAP has received U.S. Food and Drug Administration 510(k) clearance. The technology represents a landmark innovation in the blood collection industry where one billion blood draws are performed each year for diagnostic testing.

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FDA Accepts NDA Resubmission for DEXTENZA

Ocular Therapeutix’s NDA resubmission for DEXTENZA 0.4 mg for ocular pain occurring after ophthalmic surgery was accepted as a filing for review by FDA.

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FDA rejects Amphastar’s nasal opioid overdose treatment

Amphastar Pharmaceuticals Inc. said the U.S. Food and Drug Administration had rejected its application to market an intranasal version of the emergency opioid-overdose treatment, naloxone.

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U.S. FDA Accepts BLA for Mylan and Biocon’s Proposed Biosimilar Pegfilgrastim for Review

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.

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FDA approves Valeant’s drug to treat plaque psoriasis

The U.S. Food and Drug Administration approved Valeant Pharmaceuticals International’s Siliq to treat adults with moderate-to-severe plaque psoriasis.

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Special Report: Top 10 Pipelines 2017

There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.

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John Kamp: Industry peacekeeping with President Trump holds promise but portends danger

As a public official preparing for international negotiations, I was taught by the U.S. State Department to always know exactly what you want and what you’re willing to give up before sitting down with a skilled international trading partner. It looks like pharma representatives were well prepared recently when sitting down with the country’s new Negotiator-in-Chief, President Donald Trump, but they should be mindful that the other shoe has yet to drop.

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Outcomes data enters the 21st century

A lot can happen in 20 years. When the FDA Modernization Act (FDAMA) was passed in 1997, a mere 217 of its ~40,000 words were allocated to the presentation of healthcare economic information (HCEI). Those 217 words resided within Section 114 of the Act, giving birth to the abstract universe many of us now commonly refer to as FDAMA 114. Fast-forward to January 2017, and the FDA’s release of its Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance for Industry and Review Staff. Now 7,000+ words, this document is likely to significantly alter the way pharmaceutical manufacturers engage with the audience who increasingly holds the keys to its commercial success … payers such as health plans, pharmacy benefits managers (PBMs) and hospital systems.

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The brave new world of healthcare in America: Trump’s impact

The Coalition for Healthcare Communication (CHC) summit in Washington, D.C., in late November provided an interesting postmortem of the 2016 election, and a look into the crystal ball by some of our industry’s most knowledgeable leaders. Fast-forward to February 2017, and the crystal ball is still pretty cloudy.

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Drugmaker Ipsen to buy some products from Sanofi for 83 million euros

Drugmaker Ipsen has agreed to buy five consumer healthcare products from bigger French rival Sanofi for 83 million euros ($88 million), in a deal which Ipsen said should boost its profits.

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Tom Price Confirmed as HHS Chief

The U.S. Senate confirmed former Rep. Tom Price, a Georgia Republican, as the U.S. Secretary of Health and Human Services.

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FDA approves drug to treat Duchenne muscular dystrophy

The U.S. FDA approved a drug made by Marathon Pharmaceuticals to treat Duchenne muscular dystrophy (DMD), a devastating muscle-wasting disease that mainly affects young boys.

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Pharma & Biotech 2017 – Review of outsourced manufacturing

Overall, the prospects for the sector remain strong, linked to the expected growth in healthcare. There is a strong case for investment in particular segments, subject to appropriate valuation and due diligence. This report highlights some of the trends that should be in the minds of CEOs, CFOs and investors.

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FDA approves Amgen drug for SHPT

The U.S. FDA approved Amgen Inc.’s treatment for secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis.

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FTC sues Shire ViroPharma for fighting generic entry of Vancocin

The U.S. Federal Trade Commission filed a complaint against Shire ViroPharma, accusing it of abusing government processes in order to fend off generic competition to its antibiotic Vancocin HCl.

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Cellectis gets U.S. go-ahead to test ‘off-the-shelf’ cell therapy

The French biotech firm Cellectis won U.S. regulatory approval to run an early clinical trial using its gene edited cell therapy product UCART123 for blood cancers.

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U.S. FDA approves Bristol-Myers’ Opdivo for bladder cancer

The U.S. Food and Drug Administration expanded the use of Bristol-Myers Squibb Co.’s Opdivo to include treatment of urothelial carcinoma, the most common type of bladder cancer.

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New bill to spur generic drug development

A U.S. House of Representatives subcommittee will take up bipartisan legislation to spur generic drug development, the committee’s chairman said.

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