Policy & Regulation News

A list of EU member states with lead responsibility for monitoring the safety of active substances has been published online by the EMA.

The exchange of information on new psychoactive substances and abused medicines has been enhanced today, thanks to an amended working arrangement signed in Lisbon by the directors of the European Medicines Agency (EMA) and the European Monitoring Centr...

Roche announced that Lucentis (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and s...

An article in the BMJ argues that demonstrating a new drug's lack of inferiority to existing alternatives should be a formal requirement of the approvals process.

A senior Chinese medical official insists that a new regulation will help to regulate the pharmaceutical excipients industry.

GSK has announced regulatory submissions in the EU and US related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib.

The EMA's approval of the Isis manufacturing facility in California allows Isis to supply Genzyme with KYNAMRO? drug substance to support commercial launch in Europe.

The Agency has increased its level of interaction and cooperation with medicines regulatory authorities in Japan over the past three years.

Fitch Ratings predicts a fall in the number of new drug approvals in 2012.

The new policy allows the scope of a previously agreed PIP to be extended or merged if the company wishes to apply for marketing authorisation for more than one condition at the same time.

Roche has received clearance from the FDA for a fully automated vitamin D test for use on cobas? modular platforms.

The CHMP has issued a positive opinion on Glybera, which could soon become the first approved gene therapy in Europe.

The EU Commission has issued a proposed regulation to make it easier for pharmaceutical companies to carry out cross-border clinical trials.

The Agency has recommended approval of Glybera, the world’s first gene therapy drug.

China's massive investment in healthcare presents significant opportunities for pharmaceutical companies around the world.

Lupin's Pregabalin Capsules are the AB-rated generic equivalent of LYRICA capsules which had annual U.S sales of approximately $1.8 billion for the twelve months ending March 2012.

GSK will pay $3 billion in fines after reaching an agreement with the US government, several states and the district of Columbia.

The head of the EFPIA has urged EU leaders to grant concessions to prevent problems with the supply and demand of medicines in the region.

The EMA has finalised two documents providing pharmaceutical companies with guidance on how to develop medicines containing monoclonal antibodies.

The amended law allows the country to issue compulsory licences to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

Mylan is permitted to launch its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva.

US lawmakers are taking steps to increase the safety of drugs manufactured on foreign soil.

Clopidogrel is FDA-approved to treat patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery.

A study has found that US FDA generally approves drugs faster and earlier than its counterparts in Canada and Europe.

The FDA is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.

Otsuka Pharmaceutical's antipsychotic drug Abilify is protected until April 2015, preventing generic versions of the drug from being launched until that time, a US court has ruled.

Gilead Sciences has announced that a US FDA committee has voted to support the approval of the Quad regimen and Truvada.

With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme and Lumizyme produced at the 4000 liter bioreactor scale.

The Agency’s Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Forxiga, a novel treatment for type 2 diabetes mellitus.

Merck says it has won its latest lawsuit connected to osteoporosis drug Fosamax.

Johnson & Johnson has been ordered to pay $1.1 billion for failing to make clear the risks associated with its anti-psychotic drug Risperdal.

The Agency has published a new document on regulatory procedural advice on similar biological medicines.

UK's National Insitiute for Clinical Excellence has rejected Eisai's Halaven for the treatment of advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens.

The Brazilian government is tightening its gelatin production controls after pressure from the EU about consumer health concerns.

Amylin and Eli Lilly announced the marketing authorization from the European Commission for the use of BYETTA with basal insulin.

Perrigo's product is the generic equivalent to Schering-Plough's Temodar, indicated for patients with malignant glioma, where the product is currently generating over $20 million in sales in Australia.

The FDA has approved the first generic versions of Boniva tablets to treat or prevent osteoporosis.

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for Teva Pharma's Zoledronic Acid.

Watson Laboratories has submitted an Abbreviated New Drug Application with the FDA to market Nebivolol Hydrochloride Tablets, a generic version of Forest Laboratories' BYSTOLIC.

With the approval for new indication, Natazia becomes the first and only oral contraceptive indicated for the treatment of HMB.

India's Natco Pharma has been granted a compulsory license to sell a generic version of Bayer's patented cancer drug Nexavar.

The pilot allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.

Bayer HealthCare has received Australian regulatory approval for eye drug Eylea, for the treatment of neovascular (wet) age-related macular degeneration.

Arena Pharmaceuticals has filed a Marketing Authorisation Application with the European Medicines Agency for the drug. The firm expects the agency to accept it later this month.

The FDA has accepted for review Eisai's resubmission of the New Drug Application for perampanel, an investigational drug for the treatment of partial-onset seizures associated with epilepsy.

Article 57(2) of the new pharmacovigilance legislation requires the Agency to establish lists of all human medicines authorised in the European Union (EU), based on structured data submitted by the marketing authorisation holders of these medicines.

The list only includes medicines whose applications have been validated. The Agency will update this information every month following the plenary meeting of the CHMP.

The proposed prescription guidelines will be made applicable not only in the government centres that are extending treatment for HIV and TB, but also for the private health facilities and providers.

The European Commission approved an update to the Glivec (imatinib) label to include 36 months of treatment with the drug following surgery for adults with KIT (CD117-positive) gastrointestinal stromal tumors (GIST).

The guidance is intended to alert manufacturers of APIs, pharmaceutical and medical device manufacturers of finished products, re-packers, and others on the potential risk of crude heparin contamination.

Zelboraf (vemurafenib), manufactured by Roche, has been approved by the European Commission, for treating patients with BRAF V600 mutationpositive unresectable or metastatic melanoma.

The approval is based on a Phase III trial that showed a 54% reduction in the risk of disease progression amongst the 331 patients involved in comparison to placebo.

The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application that was submitted for Qnexa in October 2011.

The Agency's activities this year will concentrate on the implementation of the pharmacovigilance legislation and preparations for the new legislation on falsified medicines.

The laboratories are being planned in line with the recent regulatory measures by the Health Ministry to ensure the quality of cosmetic products both manufactured domestically and imported from outside.

Prior to FDA's approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing's syndrome.

The EMA has concluded that aprotinin’s benefits in preventing blood loss outweigh its risks in patients undergoing isolated heart bypass surgery who are at high risk of major blood loss.

FDA has notified 19 US medical practices that purchased fake 400 mg/16 mL Avastin from Quality Specialty Products (QSP), a foreign supplier that the agency said may also be known as Montana Health Care Solutions.

The guideline clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines.

The voluntary international certification scheme has been designed and developed to assure that cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients.

The NDPS policy will serve as a guide to various ministries and organizations and re-assert India's commitment to combat the drug menace in a holistic manner.

Roche announced that the FDA has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.

The drug is Shire’s top-selling pharmaceutical, achieving sales of $199.7 million in the three months to September 30 2011, up 32% on the same period in 2010.

The FDA has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older.

The European Commission has approved the use of Galvus in patients with type 2 diabetes unable to control their blood sugar with diet and exercise alone and who cannot take metformin.

The FDA has approved Merck's Janumet XR tablets, a new treatment for type 2 diabetes that combines sitagliptin with extended-release metformin.

The new pharmacovigilance legislation will significantly increase the transparency of all pharmacovigilance activities of the Agency and the European Member States.

The European Medicines Agency has issued a positive opinion recommending DCPrime’s application for orphan drug designation of dendritic cell-based cancer vaccine candidate.

Erivedge, reviewed under the agency's priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma.

FDA has approved Jentadueto tablets for patients who need to control their blood sugar.

The FDA is to strengthen the warning label on lymphoma drug Adcetris over concerns that it may be linked to brain infection.

GSK disagrees with the ruling and confirms the fine does not relate to the deaths of 14 children during the trial.

The programs include the fifth authorization of the Prescription Drug User Fee Act, and new user fee programs for human generic drugs and biosimilar biological products.

The firm was fined $93,000 by an Argentine court for failing to obtain parental consent to conduct the trials.

The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.

The Act imposes a fine of up to US$4m on individuals for a first offence and $8m for repeat offences, as well as a jail term of up to 20 years for each offence.

The new use for Prevnar 13 was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.

Janssen Research & Development, LLC has submitted a supplemental New Drug Application to the FDA seeking approval for the use of anticoagulant XARELTO.

Perrigo has received final approval from the FDA for its ANDA for Desloratadine tablets.

The clearance follows a review period during which 22 EU member states endorsed the final variation assessment report issued by AFSSAPS.

The second phase of barcoding will become mandatory from July 1, 2012 along with the third phase of barcoding on primary level packaging.

A work programme for 2012-2015 aims to strengthen the integration of herbal medicines in the pharmaceutical legislative framework.

The FDA has accepted a new drug application for tofacitinib for review.

UCERIS is being developed in collaboration with Cosmo Technologies. Upon acceptance for review of the NDA for UCERIS Tablets, $4 million is payable to Cosmo.

The revised guideline sets out the state of the art in genotoxicity testing and is expected to improve the assessment of the risks of human medicines.

Once approved by the European Commission, the 10-mg/ml syrup will provide a new treatment option that can be taken by mouth by patients who have difficulty swallowing tablets.

OPPI urges the reconsideration of para 4(2) recommendation that price regulation would not apply to any upstream products such as bulk drugs and intermediates.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP.

The latest amendment have been made with a view to look over the licensing of manufacturing, inspection and distribution of medicines to ensure quality and efficacy of the medicines.

The FDA has 60 days to review its filing and determine whether it is complete and ready for a more substantial review.

The COMP recommendations for these substances are now being sent to the European Commission for the adoption of a decision.

Synthon has submitted an Abbreviated New Drug Application for Glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes to the FDA.

Researchers have found that foul smelling frogs not only offer clues to prepare a new range of antibiotics but boost human immune system against bacterial attacks.

The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate.

Health and Human Services Secretary has overruled the decision by the FDA to make Teva Pharmaceuticals' Plan B morning-after pill available to young teens without a prescription.

The letter follows inspections between April and August this year, which uncovered ‘significant violations’ of cGMP regulations, including microbiological contamination of drug products purporting to be sterile.

This scheme covers promotion and co-ordination of basic, applied and clinical research including clinical trials and operational research in areas related to health, medical, biomedical and medical profession and education and management of related inf...

The aim of the Biomedical Catalyst fund will be to deliver growth to the UK life sciences sector through supporting and driving the development of innovative life sciences products and services.

Galvus is currently available for patients with no or mild renal impairment and this approval expands treatment options for patients with moderate or severe renal impairment1.

The company expects to commence Phase I studies of the drug candidate used for ESRD patients as soon as possible after FDA review.

SBIR grants are critical for supporting small companies with promising scientific innovation to continue critical research and development of medical advancements and breakthroughs.

Russian pharmaceutical industry has questioned the country's list of vital and essential drugs (ZHMVLP) that forbids price increases.

The FDA has granted tentative approval for the Company's Abbreviated New Drug Application for Atorvastatin Calcium Tablets.

GlaxoSmithKline has submitted additional information to the FDA in support of the Biologics License Application for its candidate meningococcal and Hib combination vaccine.

The newly-authorized quality standards have been approved by USP and will now offer a new vehicle for improving medicines quality around the world.

The six bulk drugs are frusemide, silver sulphadiazine, pentazocine, famotidine, carbamazepine and erythromycin.

The approval of KOMBOGLYZE is based on a saxagliptin development programme that involved 4,326 patients, including 2,158 individuals receiving saxagliptin plus metformin.

The approval is backed by two placebo-controlled studies which evaluated the safety and efficacy of Intermezzo for the treatment of patients with insomnia.

The approval of Rasitrio is based on pivotal phase III data involving more than 1,181 high blood pressure patients.

The European Parliament has called for tighter controls on the use of antimicrobials to fight growing resistance to bacteria.

The EMA has launched a new review on whether non-selective NSAIDs (non-steroidal anti-inflammatory drugs) can damage cardiovascular health.

The case is the final act in a legal battle over the patentability of the salt form of the anti-cancer drug imatinib and section 3(d) of the Indian patent law that stretches back over five years.

Takeda submitted a New Drug Application to the FDA for the fixed-dose combination therapy alogliptin/metformin.

Four cancer drugs and the antiviral medicine Vistide have been recalled owing to problems in the sterilisation process.

The FDA will review and act on the application for the drug, designed to treat symptomatic neurogenic orthostatic hypotension, by 28 March 2012.

Mylan has settled a patent litigation lawsuit with Novartis Pharmaceuticals related to Vivelle-Dot.

Drug pharmaceutical manufacturers, drug production industry experts opine that NMP would help to leverage the benefits from improved infrastructure, simplification of business regulations and skill upgrade measures.

The approval is based on the results of clinical studies in 630 acute lymphoblastic leukemia patients.

The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult patients. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.