AstraZeneca's tremelimumab receives US FDA orphan drug

AstraZeneca announced that the US Food and Drug Administration has granted Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma.

Mesothelioma is a rare, aggressive cancer that most often affects the lining of the lungs and abdomen. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease.

“There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care. Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients,” said Robert Iannone, senior vice president, head of immuno-oncology, global medicines development at AstraZeneca.

The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

US FDA accepts Shire's lifitegrast NDA and granted priority review status

Shire plc announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date.

The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months

“Our NDA filing for

The NDA filing is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These include one phase 2 study, two phase 3 efficacy and safety studies, and one long-term phase 3 safety study.
lifitegrast represents an important regulatory milestone, exemplifying Shire’s ability to forge new paths in therapeutic areas aligned with our focus in rare and specialty conditions,” said Philip J. Vickers, Ph.D., head of research and development, Shire. “Our commitment to moving lifitegrast forward reflects our intent to grow in the Ophthalmics therapeutic category in areas of unmet patient need.  We look forward to working closely with the FDA throughout the review process.”

Vanda Pharma receives US patent for Fanapt

Vanda Pharmaceuticals Inc. (Vanda),  a biopharmaceutical company, announced that a Fanapt patent, number 8,999,638 ('638 patent), is now listed in the US Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book.  The '638 patent was issued by the United States Patent and Trademark Office on April 7, 2015 and expires in October 2030.

Prior to this newly listed '638 patent, the Fanapt Orange Book listed patents were the US composition of matter patent and the '610 patent, expected to expire in November 2016 and November 2027, respectively.

Pfizer launches PCSK9 competitive grants programme

Pfizer Inc. announced the launch of a new competitive grants programme the company is funding to support research projects investigating the role of Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) in health and cardiovascular disease. This competitive grants programme, which is an extension of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Cardiovascular programme, is part of Pfizer's ongoing commitment to translate scientific discoveries into innovative medicines for patients with cardiovascular disease.

Pfizer currently is studying bococizumab, an investigational PCSK9 inhibitor, in a phase 3 clinical trial programme, known as SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events), for its potential to lower low density lipoprotein cholesterol (LDL-C) and improve cardiovascular outcomes.

Biocon Foundation wins ‘WHO –India Public Health Champion Award 2015’

Biocon's CSR arm, Biocon Foundation has received ‘WHO-India Public Health Champion Award 2015’ for its initiatives in the area of public health. Biocon Foundation has been recognized for its integrated healthcare initiatives through which it is constantly engaged in improving the quality of life of several thousand communities in India.

The ‘Public Health Champion Award 2015’ is a new  initiative by World Health Organization-India. The awards were presented at a national consultation held to commemorate the World Health Day 2015. Rani Desai, head of Biocon Foundation, received the award from Dr Nata Menabde, WHO representative to India, at a function held in New Delhi.



Expressing her delight at receiving the award, Rani Desai, head, Biocon Foundation said, “ The Foundation has been recognized for its innovative healthcare models of preventive and primary health services through which we are engaged in creating a sustainable health ecosystem. Through our primary health clinics we aim to enable access to affordable healthcare to rural and urban marginalized communities.”

Mylan introduces generic Generess Fe tablets in US markets

Mylan N.V. announced the US launch of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable), which is the generic version of Warner Chilcott's Generess Fe tablets.

Mylan's partner Famy Care Ltd. received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mylan's immediate shipment of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) represents the company's ninth oral contraceptive product launch in the US.

Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) had US sales of approximately $114.7 million for the 12 months ending December 31, 2014, according to IMS Health.

Baxter, Laboratoire Aguettant sign global pact for parenteral nutrition trace elements

Baxter International Inc.,  a global, diversified healthcare compan, and Laboratoire Aguettant SAS, Lyon, France, have signed an exclusive global licensing and distribution agreement for trace elements, which are essential micronutrients used in parenteral nutrition (PN) therapy. The collaboration allows Baxter to augment its leading PN portfolio, currently available in more than 90 countries, with essential trace elements.

Parenteral nutrition is an intravenous (IV) therapy, which may include a balance of protein, carbohydrates, lipids (fats), electrolytes, vitamins and trace elements for patients who cannot ingest food orally or enterally (tube-fed).