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Pediatric Exclusivity For ‘Deemed’ Biologics Needs Clarity, Industry Tells US FDA

Draft guidance says unexpired pediatric exclusivity would continue to apply to a deemed 351(a) BLA on March 23, 2020, but industry says differences in how pediatric exclusivity operates under the statutory frameworks governing drugs and biologics could result in the loss of some marketing protection.

Biosimilars Biologics Regulation

Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

Biologics Biosimilars Regulation

Germany Could Introduce Biosimilar Substitution By Pharmacists In Three Years

A German bill aims to cut spending on biologics, but new revisions mean that measures on biosimilar substitution are likely to be delayed by three years.

Europe Germany Government Payers

French Patients To Get Pre-Approval Access To Bayer’s Vitravki

Patients in France are to receive Bayer’s Vitravki through an early access scheme pending the product's EU-wide marketing authorization.
France United States Market Access

Rx Spending Growth To Be Driven By New Drug Entries, CMS Says

Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.
Reimbursement Pricing Debate Regulation
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Global Pharma Guidance Tracker – January 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Australia

Pulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem

In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Patent Settlements: FTC Gets Teva To Eschew 'No-Authorized Generic' Deals

Global settlement resolves charges against Teva in three pending FTC antitrust suits and expands terms of 2015 consent decree.

Generic Drugs Policy Legal Issues

Latest From Regulation

Latin America Inches Towards Greater Regulatory Harmonization

Executive Summary: Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.

South America BioPharmaceutical

Rare Pediatric Disease Priority Review Voucher Not Generating New Drug Trials

Researchers find no significant difference in number of rare pediatric disease treatments starting clinical development before or after incentive was created, but advocates aren't ready to give up on the program yet.
Review Pathway Rare Diseases

Competitive Generic Therapies Get Help With Development, But Not Goal Date

Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.
Generic Drugs Guidance Documents

Latest From Policy

Can Government Petition PTAB To Review Patents? Supreme Court Seems Skeptical

Justice Sotoymayor suggests 'the deck is stacked' against private citizen who is dragged by government into AIA's post-grant review proceedings. Court denies petition seeking to revive Maryland's anti-price gouging law.

Legal Issues Intellectual Property

Annuity Payment Model For Cures May Get Test Drive In Massachusetts

First-ever implementation of often-discussed reimbursement approach for high-cost drugs would involve group of commercial payers to address “portability” issue and may start with Novartis’ Zolgensma.

 

Pricing Strategies Private Payers

Germany To Increase Data Requirements For Pricing Orphan And Other Drugs

A new bill going through the German legislative process could oblige manufacturers of orphan drugs and certain other products to submit real-world data from registries that would impact pricing.

Europe Germany

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
Digital Health Drug Approval Standards

FDA's Real World Study On Adoption Of PD-1 Dosing Change Aims To Inform Reviewers

Study using US FDA’s Information Exchange and Data Transformation (INFORMED) program will focus on shift from weight-based to flat dosing for Opdivo and Keytruda.

Clinical Trials Research and Development Strategies

Commercial Explore this Topic

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Latest From Commercial

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

Generic Sensipar: Cipla Challenges Legality of Amgen/Teva Patent Settlement

Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.

Generic Drugs Intellectual Property

Puma Beats Most Of Stock Drop Suit Over Nerlynx Study Statements

Jury finds one comment in an investor call was false or misleading, limits damages award to $4.50 per share, or $64,000 for the lead plaintiff, a fraction of what was sought. Case suggests that sometimes taking a stock drop case to trial may limit liability.

Legal Issues BioPharmaceutical

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Final Rule Places Six Substances On 503A Bulks List; Rejects Four

FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and is unchanged from a proposed rule. The agency allows six bulk drug substances to be compounded by traditional pharmacies and rejects four that it had considered for inclusion, overruling the objections of pharmacy groups that argued for retaining them on the compounding list.

 

United States Manufacturing

How One Biotech Venture Is Breaking The Cost Barrier In Manufacturing MAbs For Infectious Diseases

Biotech official explains how creating partnerships with NGOs, using innovative cell cloning technology and cutting costs is allowing startup to develop new monoclonal antibody treatments for infectious diseases in developing countries, including a new MAb for Ebola.
Manufacturing Quality

Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Clinical Trials Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Moberg Sells Consumer Health Portfolio To Pay For Rx Research Focus

Moberg had been expanding its OTC portfolio while also continuing trials for Rx ingredients including its MOB-015 formulation of terbinafine indicated for fingernail and toenail fungus. But $155m agreement with two investment groups will complete Moberg's divestment of consumer health brands.
OTC Drugs Consumer

Pfizer Consumer Health True To Form Pending Move To JV With GSK

Pfizer consumer health sales up 4% to $3.6bn in 2018 as it prepares to move business into JV with GSK anticipated to close in the second half of 2019. Following 2% growth in 2017, a flat year in 2016 and a dip in 2015, Pfizer's view is confirmed of consumer health as a reliable revenue stream but not a strong growth driver.

Consumer OTC Drugs

Biotene OTC Dry Mouth Competitor Remains On Market As GSK Litigates

Former Biotene owner Laclede ordered by US federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.

Consumer Legal Issues
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