Policy & Regulation News

The new laws aim to prevent falsified medicines entering the legal supply chain and reaching patients.

There was an in-depth discussion on antimicrobial resistance and the reduced effectiveness of antibiotics due to high levels of use in humans and animals.

Pfizer has urged the court to refrain Aurobindo from manufacturing and marketing of the drug before 8 January 2017, when Pfizer's patents on the drug expires.

The FDA appeals panel voted unanimously to revoke medicine, arguing that evidence showed Avastin provided minimal benefit and carried life-threatening risks for women with breast cancer.

Taking Avastin off the market could cut Roche sales by almost $1bn annually and jeopardise treatment for an estimated 17,000 women currently using the medicine.

Following review of all available data, the CHMP concluded there was evidence of serious harm in children and adolescents receiving dexrazoxane.

The European Medicines Agency has recommended the approval of a fixed combination product consisting of dihydroartemisinin and piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria.

Emergent BioSolutions’ biodefense vaccine BioThrax has been approved by the Singapore government’s Health Sciences Authority.

The FDA has approved the first generic versions of Sanofi-Aventis antibiotic Levaquin.

The EU approval for Bydureon was based on a submission package that included data from studies in the DURATION clinical program.

The expert panel voted unanimously that the treatment should be approved to treat a neurovascular form of age-related macular degeneration.

An attempt has been made by the European Commission to end disputes between the EU and India and Brazil over EU customs’ seizure of generic medicines destined for non-EU markets.

The Council of the European Union formally adopted the Directive on Falsified Medicines, which was approved by the European Parliament last February.

A communications specialist has suggested the European Medicines Agency (EMA) establish a special board to advise on its risk communications.

Several developments have occurred during the last four years since the Union health ministry formulated the Guidelines for stem cell research regulation in 2007.

As part of being implemented in a staggered manner, the barcoding for tertiary packaging will be made compulsory only from October 1, 2011.

Potiga is the first neuronal potassium channel opener developed to treat partial seizures, the most common type of seizure seen in people with epilepsy.

Nanotechnology is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging and in cosmetics.

The updated label for insulin Humalog will allow children to use a pump and increases the amount of time recommended between changes of the pump's reservoir.

The European Commission has approved eye drug Lucentis to treat patients with visual impairment due to macular edema secondary to retinal vein occlusion.

U.K. Health Secretary Andrew Lansley has sued the French drugmaker Servier for ?220 million, claiming that the company blocked generic versions of its blood pressure drug Perindopril.

Swedish regulators have approved a knock-off version of GlaxoSmithKline's asthma drug Advair.

India's Department of Pharmaceuticals (DoP) has backed the demand of the pharma industry to postpone the deadline or relax the norms of proposed barcoding system.

Johnson & Johnson unit Ortho-McNeil-Janssen Pharmaceuticals has been ordered to pay more than $327m in a case regarding its marketing of the antipsychotic Risperdal.

India issues a Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) against the unethical marketing practice of bribing doctors by the pharma companies for prescribing their drugs.

The FDA approves a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.

Indian pharma industry is bracing up itself to move court against the introduction of bar coding mandatory for all pharma exports from July 1.

For Optimer, the FDA approval of Dificid is a key first. With an approved drug, the company can now plan to do something that many biotechs have never done--generate product revenue.

AstraZeneca announced it will no longer foot the bill for physician trips to international medical congresses.

The German health authorities approve GW Pharmaceuticals’ Sativex (Delta-9-Tetrahydro-cannabinol) and Cannabidiol oromucosal spray.

A new oral direct Factor Xa inhibitor has been approved by European Commission for the prevention of venous thromboembolic events.

With the approval of Incivek, there are now two important new treatment options for hepatitis C.

The European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis.

Sutent becomes the second new approval by the FDA to treat patients with progressive neuroendocrine cancerous tumors.

The FDA has approved Edurant in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults.

These three medicines are expected to become blockbusters, helping to replace revenues that GSK, Merck and BMS will lose as some of their big drugs go off patent.

If the exporters are forced to implement it in the present form before the deadline ends, the total pharma exports from India will come to a standstill.

Advisors to the US Food and Drug Administration voted unanimously to support Merck's drug, which beat Vertex Pharmaceuticals' hepatitis C treatment telaprevir in its race for clearance.

Biogen Idec will try to get government reimbursement for Fampyra, and expects the drug to be available to Australian patients starting in October.

India has introduced the auditing and inspection of manufacturing facilities in foreign countries to ensure quality of importing pharmaceutical products into the country.

Fluzone Intradermal vaccine will be available to healthcare providers in the US for the 2011–2012 influenza season.

The fast-track process is designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need.

Orphan status entitles Mithridion to seven years of market exclusivity upon approval of MCD-386 for treating PSP.

As part of enforcing the guidelines, the Ministry has issued direction on transfer of human biological material for research and commercial purposes.

Afinitor? was previously approved to treat other cancer types, but needed to prove effective in patients with pancreatic neuroendocrine tumors.

The FDA has approved esomeprazole sodium for injection as a new short-term treatment option for children suffering from gastroesophageal reflux disease with erosive esophagitis.

With this approval, BSPC will become the first Chinese-owned pharma firm to be able to launch an FDA-approved oral solid dose product on the U.S. market.

Sun Pharmaceutical announced that USFDA has granted its subsidiary an approval for its New Drug Application (NDA) for DOCEFREZTM (docetaxel) for Injection.

The EMA is working with regulatory partners to monitor and evaluate the possibility of radioactive contamination of medicines manufactured in Japan.

AndroGel 1.62% showed it can restore and maintain testosterone levels in men for up to one year.

The new consultation is a concept paper on revisions to Chapter 8 of the GMP Guidelines on Complaints and Product Recall.

This new legislation claims to put consumer’s safety first by banning the ayurvedic and other herbal products in Europe.

Tradjenta was demonstrated to be safe and effective in eight clinical studies involving about 3,800 patients with Type 2 diabetes.

The FDA's Antiviral Drugs Advisory Committee has voted to support the approval of Merck's Victrelis for the treatment of chronic hepatitis C.

The FDA has approved Zytiga in combination with prednisone for patients with late-stage castration-resistant prostate cancer.

The US state of Vermont claims that the 'data-mining' practice violates patient-doctor confidentiality and that it is increasing the cost of prescription drugs.

Health Canada has extended the indication of GARDASIL? in women up to the age of 45.

The FDA released the 50-page Strategic Priorities 2011 - 2015: Responding to the Public Health Challenges of the 21st Century.

The decision to withdraw the application was based on the fact that the CHMP considers that the data provided do not allow the it to conclude on a positive benefit-risk balance.

Governments have promised to modernise Canada's antiquated laws governing therapeutic drugs since 1995 — only to balk on the threshold of change, at best tinkering around its edges,' said Hébert.

The drugs affected by FDA's move include long-acting and extended-release opioids such as oxycodone, morphine and methadone.

The FDA has approved Genentech's Actemra as a treatment for active systemic juvenile idiopathic arthritis.

The FDA told Lilly it would need to conduct another study of a new treatment before it could expect an approval.

The U.S. FDA approved Rituxan, in combination with glucocorticoids, to treat patients with two rare disorders that cause blood vessel inflammation.

The U.S. FDA has approved Merck's SYLATRON for injection, for subcutaneous use.

Under the new scheme, pharmaceutical companies are more likely to find their drugs 'red-listed', which means they can only be prescribed by a hospital and not a GP.

J&J has agreed to pay $70 million to settle allegations that it bribed doctors in Europe and paid kickbacks to win contracts in Iraq.

The FDA has allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever.

The FDA has approved tablets developed by GSK and XenoPort for the treatment of moderate-to-severe primary Restless Legs Syndrome.

The day is focusing on topics relevant to the Paediatric Regulation.

The vaccine failed to provide adequate results for trial patients and also didn't prevent cervical dysplasia or other HPV-related diseases in the 27 to 45 age range.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing ...

The draft document summarises recommendations for companies preparing mock-ups and specimens of the packaging of non-prescription medicines authorised through the centralised procedure.

The registration statement relating to the Contingent Value Rights offered to Genzyme shareholders as part of sanofi-aventis' agreement to acquire Genzyme has been declared effective.

The announcement from the Union Health Ministry of India said it will not take a 'hasty decision' on use of 2D barcoding for drug tracking.

APP Pharmaceuticals announced that it has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection as a precautionary measure.

The U.S. Pharmacopeial Convention is working with the FDA and the Consumer Healthcare Products Association to update the quality standards for common medicines.

The UAE has become the latest country to approve Gilenya.

Novartis received approval from the European Commission for Gilenya. The approval will make the treatment available to more eligible MS patients.

The National Institutes of Health has announced a new strategic plan to guide diabetes-related research over the next decade.

The FDA accepted an expert panel's recommendation and reject Amyvid, a new molecular imaging agent that could revolutionize Alzheimer's diagnosis.

The country's drug price regulator has now fixed the 60ml package price at INR39.60.

NICE explains that it is not sure that trabectedin extends patients' lives for longer than the most routinely used treatments.

Novo Nordisk has received marketing authorisation for Victoza in Europe, the US, Canada, Japan and a number of other countries, now including China.

With the additional workstations, Dendreon expects to have approximately 225 infusion centers prepared to treat their first patient by the end of the 2Q11.

Chairman of GSK Research and Development said, 'The approval of Benlysta is an important step for appropriate lupus patients.'

AstraZeneca was charged with marketing Seroquel and now the company has agreed to pay $68.5m to 36 US states and the District of Colombia to resolve allegations.

The first new drug to treat lupus in more than 50 years, developed by Human Genome Sciences, was approved by the FDA.

NICE, a UK health watchdog, has rejected two cancer drugs that it was hoped would be made available on the NHS.

The EC has approved Janssen-Cilag’s XEPLION (paliperidone palmitate) for the treatment of schizophrenia.

The FDA has accepted Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes.

The US Supreme Court has declined to act on patent settlements by drug companies following allegations that they may violate federal antitrust laws.

Covance announced yesterday that the Association for Assessment and Accreditation of Laboratory Animal Care awarded full accreditation to the company's early development research facility in Shanghai, China.

The FDA has accepted the new drug application by Handa Pharmaceuticals for Dexlansoprazole delayed-release capsules.

China comes to getting a WHO approval on its vaccine-making regulatory system which may open the door for China to become a supplier to the United Nations vaccine programs.

Sinovac Biotech Ltd., a China-based biopharmaceutical company, announced it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine to China's SFDA.

The first drug manufactured for multiple-sclerosis has been rejected by FDA.

Excella GmbH has met the criteria of the SafeBridge program for Potent Compound Safety Certification and has been deemed competent and proficient in the safe handling of potent APIs.

Regulators in the USA gave the thumbs-up to the chronic obstructive pulmonary disease drug roflumilast.

The FDA has approved the phosphodiesterase-4 inhibitor roflumilast (Daliresp) to prevent COPD exacerbations.

The world's largest drug maker Pfizer has been approved to sell the Dupuytren's contracture treatment Xiapex in European markets.

To pre-clinically investigate the use of DSC127, the US Government has awarded Derma Sciences a $4.5m grant, in the treatment of skin injuries associated with acute radiation exposure.

The European Medicines Agency has updated the guideline on medicinal products for the treatment of insomnia.

Takeda has applied for US FDA approval for its new hypertension drug after its completion of four Phase III clinical trials.

FDA has approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

The European Parliament has passed a directive aimed at curbing the sale and distribution of counterfeit drugs.

Suppliers of herbal and Chinese medicines in the UK will be able to avoid a ban on supplying unlicensed products.

BrainStorm Cell Therapeutics has received orphan drug designation for the treatment of amyotrophic lateral sclerosis.

The US Food and Drug Administration (FDA) budget is set to rise to $2.7bn, but the increase contradicts proposals set by House Republicans.

The new GMP is crucial to upgrading the country's pharmaceutical sector and will bring the pharmaceutical industry closer to international drug manufacturing standards.

Bayer's investigational compound regorafenib has been granted orphan drug status by FDA for the treatment of patients with gastrointestinal stromal tumours.

The UK government has outlined its expectations of the drug supply chain with new practice to respond to the drug shortages.

The European Medicines Agency has launched a new version of its EudraGMP database with information on manufacturing inspections.

Pharmetics Inc., a manufacturer of OTC drugs, has voluntarily recalled six health products currently on the Canadian market.

The European Medicines Agency has released new guidance covering the different types of stem cells used in medicines.

Albany Molecular Research, Inc. receives the GMP manufacture approval from the Italian Medicines Agency.

GSK received a complete response letter from the FDA rejecting Avodart as a way to reduce the risk of prostate cancer for now.

The FDA has granted BMS and Sanofi-Aventis a six month extension for the exclusive rights for Plavix.

India will implement new packaging regulation on its exported drugs and pharmaceuticals in July this year.