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FDA Mulls Program to Let Drugmakers Reserve Proprietary Name

The FDA is considering letting branded drugmakers reserve a proprietary name for a new product, with the goal of avoiding potential delays by approving permanent drug names well in advance of product launch.

GSK Submits Application to EMA for First Malaria Vaccine

British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative.

FDA Aims to Minimize Potential for Coercion in Updated Clinical Trial Informed Consent Requirements

Sponsors designing trials involving certain vulnerable patient populations such as limited or non-English speakers, dementia or traumatic brain injury sufferers and children will soon face greater scrutiny from institutional review boards under newly issued FDA guidance.

Lilly and BI Insulin Biosimilar Wins Positive CHMP Recommendation

A key European panel has recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product.

Expert: How to Know When a Trial Is Applicable to

Not all clinical trials need to be registered on, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says.

Panel: No Need for Cardiovascular Trials for Opioid Constipation

Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel tenuously concluded June 12, noting that it may be wiser to require postmarket observational studies.

FDA Revises Uncomplicated Gonorrhea Draft Guidance

The FDA is making minor changes to its recommendations for sponsors developing new treatments for all types of uncomplicated gonorrhea.

Duchenne Community Submits First-Ever Patient-Initiated Draft Guidance to FDA

A coalition of muscular dystrophy advocates, researchers, clinicians and drug manufacturers has submitted the first-ever patient-initiated draft guidance on drug development to the FDA, a move prompted by the agency’s efforts to get more patient perspectives into the drug approval process.

‘Right to Try’ Experimental Drug Legislation Introduced by States

Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA.

Bristol-Myers Squibb Cancer Therapy Prolongs Melanoma Survival

Company stops a Phase III Trial of nivolumab after showing superior survival compared to chemo.

Vertex Cystic Fibrosis Drug Combo Improves Lung Function in Study

The company said it plans to apply for FDA and European approval in the fourth quarter.

Boehringer Ingelheim Drops Hepatitis C Development

Company says there is no longer an unmet need for its treatment, faldaprevir.

States Introduce ‘Right to Try’ Experimental Drug Legislation

Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies.

Vertex, Janssen Collaborate on Investigational Flu Medicine

Each year, up to 20 percent of the U.S. population gets the flu, resulting in more than 200,000 flu-related hospitalizations and 36,000 deaths.

Australia’s TGA Considers Adoption of EU Drug Guidelines

Australia’s pharmaceutical regulatory body is looking to Europe for guidance on drug development, including clinical development of similar biological drugs, investigations of lipid disorder therapies and evaluations of bacterial infections.

Sanofi Canada Becomes Eighth Member of CQDM

Company will invest up to $500,000 into the Quebec Consortium for Drug Discovery.

FDA Panel: No Need for Cardiovascular Outcomes Trials for Opioid-Constipation Drugs

Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies.

EMA to Publish Clinical Trial Data Beginning in October

The European Medicines Agency (EMA) approved a controversial policy last week that will grant researchers access to detailed clinical trial data submitted in support of drug approvals.

Johnson & Johnson and GSK Team Up to Develop HIV Combo Pill

Drug will combine two treatments in one and challenge Gilead’s best-selling Atripla.

BIO and NORD Want Clarity in Guidance on Orphan Product Development

The FDA should issue guidance on orphan drug development that provides a detailed set of deadlines and clarity on what exactly will be discussed at various meetings throughout the approval process, according to an industry trade group.

FDA/EMA Strategic Plan Targets Drug Treatments for Gaucher in Kids

Clinical investigators looking to develop new therapies for children with Gaucher disease may use multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the FDA and European Medicines Agency.

New Guidance on Developing Drugs Under the Animal Rule

Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule.

EU OKs Second Trial Partnership With Developing Countries

Eight African nations have signed up to participate in the second European & Developing Countries Clinical Trials Partnership, with a ninth expected to follow suit soon.

More Drugmakers Agree to Share Clinical Study Data Online

Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators.

EU Publishes Clinical Trials Regulation; Drugmakers Must Justify CCI Redactions

Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says.

AstraZeneca, Gustave Roussy Partner in Anti-Cancer Drug Development

Gustave Roussy will gain access to AstraZeneca’s entire portfolio of oncology molecules.

EMA Selects Two Medicines for Adaptive Licensing Project

The European Medicines Agency has selected the first two drug candidates for inclusion in a pilot project, known as adaptive licensing, that aims to speed patient access to new treatments.

FDA Adds Three Pathogens to Hit List in Final Guidance on Developing New Antibiotics

The FDA has added three new pathogens to the list of infectious agents that drugmakers can target to receive accelerated approval and extended market exclusivity under the agency’s program aimed at antibiotic-resistant infections.

NeuroVive Extends Collaboration with French Hospital, Hospices Civils de Lyon

Collaboration gives NeuroVive access to research findings and rights to projects.

BMS and Syngene Extend R&D Collaboration for Five More Years

The collaboration has created six drug candidates for future study.