Policy & Regulation News

The European Patent Office has granted a patent for endocannabinoid modulator Sativex with an exclusivity period until August 2023.

Jakafi has become the first drug approved to specifically treat patients with the bone marrow disease.

The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA.

CPI-300 is a single dose 450mg formulation of bupropion hydrochloride for the treatment of major depressive disorder.

The FDA has granted orphan drug designation to the Japanese pharmaceutical company's sirolimus drug.

The FDA has approved Hemacord for the treatment of blood forming disorders or cancer.

Amgen announced that the European Commission has approved to extend the therapeutic indications for Vectibix, a therapy to treat colorectal cancer.

The DoP is learnt to have taken up the matter with the Ministry of Commerce for imposing anti-dumping duty. However, the Commerce Ministry is still studying the matter and a decision would be taken up after analysing all related aspects, sources said.

The new edition includes tools to help pharmaceutical manufacturers meet safety requirements while avoiding unnecessary cost.

The FDA has granted fast-track designation to Opexa Therapeutics' Tovaxin drug candidate against secondary progressive multiple sclerosis.

Merck has received two rejections from the US FDA. The company plans to discuss the rejections with the FDA.

The settlement is to end the arbitration and litigation related to certain intellectual property emerging from a 1992-1995 research collaboration.

The FDA has approved Erbitux for use with chemotherapy to treat patients with late-stage head and neck cancer.

The FDA indicated that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to discuss the Qnexa NDA in the first quarter of 2012.

GSK has agreed to pay $3bn to settle all US investigations into the way the company marketed and developed its products.

India is to extend its price control of essential medicines from the current 34 to at least 400 drugs.

FDA approves Endo Felodipine Extended-release Tablets USP, which are the generic version of AstraZeneca's Plendil Extended-release Tablets.

The Medicrime Convention is the first international treaty that obliges signatory states to criminalise the counterfeiting of medical products and similar crimes.

NICE approved the drug for use for up to 12 months as a treatment option for patients who have had a hear attack or an episode of unstable angina.

The new process is expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process.

The drug candidate has completed a Phase I study and expects to go into a Phase II proof-of-concept study to assess its clinical benefit.

Sagent Pharmaceuticals' bupivacaine hydrochloride injection wins FDA approval and will be available in six single-dose and two multi-dose latex-free vials.

The working group of the World Health Organisation will held its second meeting on the issue of spurious drugs from October 25 to 28 at Geneva.

EU regulators have launched investigation focused on a suspected agreement between Johnson & Johnson and Novartis to delay the sale of a generic painkiller in the Netherlands.

NSAIDS have been the subject of several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions.

A three-member delegation of the Central Drugs Standard Control Organization will leave for China next month to inspect a total of six diagnostics and bulk drug units there.

The Phase I/IIa study will enroll around 18 patients with Usher syndrome type 1B and assess three dose levels of UshStat for safety, tolerability and aspects of biological activity.

India is considering the need for special financial package to boost the exports of pharma products from India.

The new guidance describes how firms can move from established baseline practice to a more efficient science- and risk-based framework.

The European Court of Justice has banned the issuing of patents for embryonic stem cell research, in a case that could have major implications for medical research.

India's pharma industry may move court against the union commerce ministry's notification dated 10th January, 2011 under which barcoding was made mandatory for pharma exports, if the government does not amend the notification to make it exporter friend...

The company stated that they were unable to demonstrate to the satisfaction of the CHMP an overwhelming effect showing that the benefits of Luveniq outweigh its risks, and thus would qualify for a recommendation for authorisation with one pivotal study...

New draft guidance from the NICE recommends against the use of ipilimumab for advanced malignant melanoma in people who have received prior chemotherapy.

Watson Laboratories has filed an Abbreviated New Drug Application with the U.S. FDA for the marketing approval of Methylphenidate Transdermal System.

The move is considered to be a measure to motivate and encourage Pharmexcil members in export trade of pharmaceuticals.

The FDA said the drug can increase the risk of pulmonary arterial hypertension. The potential risk has been added to the warnings and precautions section of Sprycel's label.

The U.S. FDA has approved a New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

Baxter International has submitted an application to the EMA seeking marketing authorisation for the company's investigational immunoglobulin therapy.

The FDA approves Juvisync tablet, the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet.

The NDA submission is based on results from a 12 week double-blind placebo-controlled Phase 3 trial involving 350 rheumatoid arthritis patients.

Lannett Company has received approval from the FDA for its Loxapine Capsules in 5mg, 10mg, 25mg and 50mg doses.

A strategic paper by the Indian Commerce Ministry calls for critical policy interventions and special efforts to increase the presence of Indian pharma industry in China.

AstraZeneca has received regulatory approval for its breast cancer drug Faslodex (fulvestrant) 500mg in Japan.

Takeda has submitted a New Drug Application in Japan for TAK-085 for the treatment of hyperlipidemia.

Under the new initiative, Medicare will work with commercial and state health insurance plans to offer additional support to primary care doctors who better coordinate care for their patients.

The Japanese regulators have approved Novartis' once-daily Gilenya (fingolimod) 0.5mg and Illaris (canakinumab) subcutaneous injection 150mg in the Japanese market.

The scheme released by India's Department of Ayush aims to promote availability of quality plant based raw material.

Boehringer Ingelheim has received European approval for its once-daily Viramune tablets for HIV treatment.

Canadian regulators have given approval of Banzel for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Tokai Pharmaceuticals has received $23m funding in a Series D3 financing to support its ongoing clinical development of galeterone.

Janssen's Remicade has been approved by FDA to treat moderately to severely active ulcerative colitis in children older than 6 years who have had inadequate response to conventional therapy.

The FDA has approved Soliris to treat patients with atypical Hemolytic Uremic Syndrome that can lead to kidney failure and is also associated with increased risk of death and stroke.

Due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be prescribed after alternative treatment options have been considered.

The EMA is reviewing relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations should be revoked, suspended or changed.

The recommendation follows the voluntary recall of Vimpat 15mg/ml syrup on 15 September 2011. The recall was initiated because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup.

NIH is reducing both the cost and paperwork requirements for start-up companies to obtain an exclusive option agreement to license the extensive patents and patent applications from research laboratories.

The investigation is focused around active ingredient ondansetron. It is feared that the ingredient could cause QT interval prolongation, potentially leading to abnormal heart rhythms.

The FDA has granted orphan drug designation to Avedro's VibeX solution for use with its KXL System for corneal cross-linking to treat keratoconus.

The approval comes after an accelerated regulatory review process by the European Medicines Agency (EMA) and a positive CHMP opinion.

With this move, the number of drugs sold over the counter (OTC) in pharmacies may come down in the near future.

A report says the post-2016 U.S. pharmaceutical industry revenue impact of the Affordable Care Act will be 20 percent, which is larger the 3 percent estimates that were widely circulated before.

The European Commission has approved Afinitor? (everolimus) tablets for the treatment of neuroendocrine tumors of pancreatic origin in adults with progressive disease.

The FDA has issued a draft of guidance to the pharmaceutical industry on Tablet Scoring: Nomenclature, Labelling, and Data for Evaluation.

The US FDA has granted fast track status to AiCuris' HCMV drug Letermovir.

FDA currently prevents generic drug makers to update labels even if they are made aware of an unstated risk to the consumer, as they must remain identical to the original brand-name product.

This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations.

The FDA requested additional information surrounding canakinumab including clinical data to evaluate the benefit-risk profile in refractory patients.

Pfizer announced that it received US approval for its lung cancer drug Xalkori.

The approval follows J&J's study showing the safety and efficacy of the drug in Phase III studies.

Algeta's radium-223 chloride has been granted fast-track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.

The approval of linagliptin in Europe was based on a clinical trial program which involved approximately 6,000 adults with type 2 diabetes.

Fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition.

Vertex Pharmaceuticals receives Health Canada approval for Incivek tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease.

According to EMA's note, new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.

Yervoy, the first advanced skin cancer drug since the 1970s, has been awarded a European licence.

Approximately 27,000 Canadians suffer from RVO every year making RVO the second-most common cause of vision loss due to retinal vascular disease after diabetic retinopathy.

Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival in patients with late-stage melanoma.

The EMA has accepted Pfizer's regulatory submissions for review of two investigational compounds, crizotinib and bosutinib.

Following the approval, the firm has accepted orders for the products through their distributor, Nutritional Alliance, for export to India-based importers.

Pfizer has won a patent infringement case that prevents Teva from marketing a generic version of Viagra.

Not everyone has seen user fees as a good idea, with critics raising questions about the idea of the FDA receiving funding from the very companies it's regulating.

The joint center will be established for joint research, educational training, collaborations and outreach in support of the FDA's mission to protect and promote public health.

Avanir Pharmaceuticals said it filed lawsuits against Par Pharmaceutical and Actavis, alleging infringement of patents related to its involuntary-emotion drug.

The approval of Complera is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies.

FDA grants an orphan drug designation for Kamada's Alpha-1 Antitrypsin drug to treat type 1 diabetes.

The submission includes efficacy and safety data from a Phase 3 program comprising four double-blind placebo-controlled trials and two open-label long term safety studies.

The FDA has accepted for filing Teva's New Drug Application for a nasal aerosol corticosteroid in development for the treatment of allergic rhinitis.

Regulators in Europe have given approval to Boehringer Ingelheim's oral anticoagulant Pradaxa for stroke prevention.

Merrimack Pharmaceuticals' pancreatic cancer drug has received orphan drug status approved by the FDA.

Teva holds marketing rights for new oral contraceptive tablet in France, Italy, Belgium and Spain and expects the first launch in 2011.

Hospira is the first company to offer gemcitabine in a solution formulation for the U.S. market. The solution formulation is designed to improve pharmacist convenience and handling safety.

The policy seeks to streamline the decision-making process on new and underutilised vaccine introduction, besides addressing issues of vaccine security, management, regulatory guidelines, vaccine research and development, and product development.

Covidien has received the FDA approval for its Mallinckrodt business for morphine sulfate oral solution.

Roche has won European approval for broader use of its arthritis drug RoActemra to treat children with a rare and severe form of the disease.

The Securities and Exchange Commission has charged a California-based biopharmaceutical company, three shareholder companies, and four senior executives for fraudulently misleading investors about the regulatory status of the company’s sole produc...

AstraZeneca's AXANUM for prevention of cardiovascular events has received positive agreement for approval in 23 European Union member countries and in Norway.

Covidien has received approval from the FDA for morphine sulfate oral solution used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.

BMS says Orencia is the only biologic for treating RA that has been approved both in an intravenous infusion formulation and as a self-injectable subcutaneous formulation.

Eli Lilly won an appeals court ruling in its effort to block generic versions of attention-deficit treatment Strattera.

FDA has issued a Refusal to File letter in response to the company's New Drug Application for perampanel.

Under terms of the approval conditions, the European regulator is recommending the firm carry out a further study to evaluate long-term benefits and safety of the drug.

The Guide aims to define current best practices within pharmaceutical manufacturing applications in regards to gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.

The drug manufacturer hopes the FDA will approve alogliptin as a stand-alone treatment and as a single-pill therapy in combination with pioglitazone, a previously approved drug.

EMA recommends orphan drug designation for 4SC's resminostat to treat hepatocellular carcinoma.

Health Canada has issued a notice of compliance for the first medicine approved in Canada for the treatment of hyponatremia.

The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India.

Antimicrobials are needed to control infectious diseases in both humans and animals for reasons of public and animal health and the CVMP strategy aims to minimise the risk to humans from the use of antimicrobials in animals.

EMA recommends that in persons under 20 years of age Pandemrix may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed.

The health board said that although the drug could potentially help patients live a little longer, it also caused more negative side effects than other treatments.

AstraZeneca announced the FDA has approved its blood-thinning drug Brilinta.

Sun Pharmaceutical has received the US health regulator's nod to market alfuzosin hydrochloride tablets, used in the treatment of prostatic hyperplasia, in the American market.

The FDA advisory committee's votes followed what many industry watchers viewed as a mixed agency staff review of Seattle Genetics' application for approval of the drug for blood cancer.

The recommendation of the FDA's Oncologic Drugs Advisory Committee is not the final decision. Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer.

Bayer has lost European patent protection for birth control pill Yasmin.

The EMA releases a reflection paper on use of 'genomic markers' in the development and testing of human medicines for public consultation.

By inserting the regulations for environmental control among production regulations within the framework of GMP, legislation will have an impact on third world countries.

The European Commission ends an antitrust probe of Boehringer Ingelheim after the company agreed to remove obstacles to rival products.

Johnson & Johnson subisidiary Janssen Pharmaceuticals has announced its FDA approval for Xarelto, a novel, once-daily, oral anticoagulant.

Novartis has received approval in Japan for Onbrez Inhalation Capsules for the treatment of chronic obstructive pulmonary disease.

Pharmacies receive prescriber-identifying information when processing prescriptions and sell the information to 'data miners', who produce reports on prescriber behaviour and lease their reports to pharmaceutical manufacturers.