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Mylan Communications With CMS To Get Outside Review Under EpiPen Settlement

Corporate integrity agreement requires Mylan to have an independent body review its drug classifications and US best price determinations; settlement resolves claims Mylan misclassified EpiPen to underpay rebates. Sanofi acted as whistleblower in case.

Reimbursement Compliance Government Payers

South Africa To Tighten Up On Patenting To Promote Innovation, Improve Medicines Access

Reforms proposed in the draft South African policy on intellectual property and public health that has just been put out for consultation have been welcomed, with some caveats, by industry and health activists alike. In this first instalment of a two-part article we look at plans to tighten up on the way that patent applications are examined, granted and opposed. The second part will examine other aspects of the policy in areas like voluntary and compulsory licenses, parallel importation, and boosting local manufacturing.

Intellectual Property South Africa Market Access

FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors

New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.

FDA Research & Development Regulation

Clinical Data Forgers Face Harsh Punishment In China

China FDA now has more solid ground to enforce GCP norms. A legal explanation from the nation's highest People's Supreme Court clarifies responsibilities of study sponsors and CROs involving in data falsification.

Clinical Trials Research & Development China

Policy & Regulation Explore this Topic

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Updated EU Guideline On Manufacturing Finished Dosage Forms Addresses Supply Chain Complexities

New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.

Europe Manufacturing BioPharmaceutical

Latest From Regulation

Historical Control In Psoriatic Arthritis May Hinge On Background Therapy

FDA says during meeting on Xeljanz application that it is interested in feedback on creating a control group for non-inferiority trials.

Biologics Clinical Trials

Could FDA Force Pfizer To Push Shingles Vaccination With Xeljanz Psoriatic Arthritis Approval?

Arthritis Advisory Committee members say the company should bear some of the responsibility for managing the risk of shingles with the JAK inhibitor.

Advisory Committees Risk Management

Pharma Wants More Clarity On Use Of Auxiliary Products In EU Trials

Pharmaceutical companies say that more clarification is needed on a European Commission proposal that offers a revised definition for investigational medicinal products and deals with the use of auxiliary medicinal products in clinical trials.

Clinical Trials Regulation

Latest From Policy

Multiple Sclerosis Drug Price Increases Probed By House Oversight Panel Democrats

Reps. Cummings and Welch contact seven manufacturers of multiple sclerosis drugs with inquiries about persistent and significant annual price increases. The members suggest some firms are boosting prices in "lockstep."

Pricing Debate Policy

Par Alleges 'Shocking' Trade Secret Theft By QuVa Pharma

Par says former employees who founded QuVa used Par's trade secrets to develop a vasopressin product, which FDA has added to its list of ingredients for drug compounding.

Intellectual Property Policy

White House Advisor Philipson Brings Industry-Aligned Views On Drug Value

Tomas Philipson, a University of Chicago professor and consultant to the pharmaceutical industry, is named to the White House Council of Economic Advisors.

Appointments Pricing Debate

Clinical / R&D Explore this Topic

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Latest From Research & Development

Medically Senseless: Why EU Pediatric Investigation Plans Should be Abandoned

Most clinical trials required under EU pediatric investigation plans are medically senseless, and many cause harm to patients, argues consultant Klaus Rose. This is a challenge not only for the pharmaceutical industry but for regulators and wider society as well.

Pediatrics Europe

Keeping Track Of CRLs: US FDA Again Faults Bausch + Lomb Manufacturing

A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.

Complete Response Letters Regulation

English PrEP Study To Use Mylan’s Generic Version Of Gilead’s Truvada

A study of tenofovir plus emtricitabine in HIV pre-exposure prophylaxis is to begin in England in September, using Mylan’s generic version of Gilead’s originator drug Truvada. Wales is running a similar trial with Truvada, while Scotland has decided to fund the drug for PrEP under the National Health Service.

Clinical Trials Cost Effectiveness

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Latest From Commercial

Commercial Capsules: BMS's Opdivo Knock; Novo Nordisk Vs Eli Lilly; Roivant Raises; Sun Plunges; Other R&D Stumbles

Bristol-Myers Squibb faces a second clinical disappointment with Opdivo/Yervoy, allowing Exelixis to take advantage; Novo Nordisk claims a victory over Eli Lilly in the GLP-1 space; Roivant Sciences closed a $1.1bn equity financing; India’s biggest drug firm, Sun Pharma, slid into the red; Regeneron drops out of RSV; and Zynerba's cannabidiol gel misses again. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Clinical Trials Commercial

Policy People In The News: Patrick Conway Departs CMS

Conway, a champion of the US agency's move into value-based care, will take the helm at Blue Cross/Blue Shield of North Carolina; Biogen, Astellas, Myovant make executive changes in policy operations.

Appointments Companies

Commercial Capsules: Autoimmune Positioning; Sanofi In China; Migraine Race; BMS Deal; Clinical Advances

AbbVie outlines how it will stay top dog in autoimmune therapy; Dermira licenses lebrikizumab, threatening pressure on Sanofi/Regeneron's Dupixent; Sanofi has driven up vaccine sales in China after responding to new government distribution rules; Lilly plans a migraine filing; FibroGen, Myokardia and Hansa Medical advance in the clinic and Bristol-Myers shells out up to $2.3bn to turn cold tumors hot. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Clinical Trials Deals

Manufacturing Explore this Topic

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Latest From Manufacturing

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

EU Member States Taking New Steps To Tackle Drug Shortages

The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.

Distribution Manufacturing

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Trademarks

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Latest From Consumer

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Trademarks

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.

Consumer Manufacturing

NHS England Tackles Use Of ‘Ineffective And Dangerous’ Medicines

The National Health Service in England has drawn up a proposed list of “ineffective and dangerous” medicines that should not be routinely used in primary care, in a move to conserve resources and improve patient outcomes. They include products containing substances like fentanyl, tadalafil and trimipramine, as well as homeopathics and traditional herbal medicines.

Cost Effectiveness Drug Safety