Pharmaceutical Sector

Merck’s Keytruda is more Effective Treatment of Advanced Melanoma

Merck’s Keytruda is more Effective Treatment of Advanced Melanoma

Pharmaceutical company Merck announced on Tuesday that it has received positive results from Phase III trial of Keytruda drug. The company stated that the drug met its two primary endpoints in the study as first-line treatment for patients with melanoma.

In the trial, the company has included a total of 834 patients. The patients were given Keytruda 10mg/kg every three weeks, Keytruda 10mg/kg every two weeks, or four cycles of ipilimumab 3mg/kg every three weeks. According to the company, the patients who received Keytruda showed meaningful improvement in overall survival, compared with patients receiving Bristol-Myers Squibb Co.'s ipilmumab and Yervoy.

Hepatitis C Drugs ‘Harvoni and Sovaldi’ have Potentially Lethal Risk: Gilead Sciences

Hepatitis C Drugs ‘Harvoni and Sovaldi’ have Potentially Lethal Risk

Shares of Gilead Sciences Inc, the biotechnology company, dropped 2% on Monday after the company revealed about the potential lethal risk associated with patients treated with its top-selling hepatitis C drugs.

The company said it has sent cautionary emails to several healthcare providers on Friday in order to notify them about the nine cases in which patients were treated with its Harvoni or Sovaldi.

It also warned that patients taking heart drug amiodarone might suffer a slow heart beat condition known as symptomatic bradycardia.

It was found that the condition for the first was seen immediately in six of the patients. Three of the nine patients immediately required placement of a pacemaker and rest were given a beta blocker, which slows heart rates.

MEI Pharma’s Cancer Drug Pracinostat Fails Phase-2 Clinical Trial

MEI Pharma’s Cancer Drug Pracinostat Fails Phase-2 Clinical Trial

After MEI Pharma announced that its cancer drug Pracinostat has not derived good results in a phase-two clinical trial, the company's shares lost more than two-thirds of their value on Monday.

Experts shared that the San Diego biotech's shares closed at $1.93, down $4.37, or 69%. On Friday, the company's shares closed at $6.30.

The company said that the drug was not able to provide complete remission in combination with another cancer drug in comparison to other cancer drug alone. Pracinostat was tested along with azacitidine on a blood cancer called myelodysplastic syndrome.

Zydus Cadila Launches Generic Version of Gilead Sciences’ Hepatitis C drug in India

Zydus Cadila Launches Generic Version of Gilead Sciences’ Hepatitis C drug

Pharmaceutical companies across the globe have been spending lot of money in research to find out effective treatments for Hepatitis C. In India, more than 10 million people suffer from Hepatitis C, which was earlier considered to be an incurable problem.

Today, Zydus Cadila has launched a generic version of Gilead Sciences’ Hepatitis C drug Sofosbuvir in India. The drug has been launched under the brand name ‘SoviHep’. Both the companies, Zydus and Gilead Sciences, have signed a non-exclusive licensing agreement.

As per the agreement, manufacturing of Gilead Sciences’ Hepatitis C drug Sofosbuvir can be done and also allows the distribution of fixed-dose combination of ledipasvir/sofosbuvir in 91 countries even in India.

Glaxo’s asthma treatment under review

Glaxo’s asthma treatment under review

According to Reuters, GlaxoSmithKline Plc’s new respiratory treatment for chronic breathing problems is being reviewed to ensure the safety of the drug over long term use to treat asthma patients.

According to the US Food and Drugs Administration (FDA), they are conducting review of the treatment and are also carrying out the discussion on approval of the combination treatment, Breo Ellipta.

The agency has already approved the inhaled drug combination of vilanterol and corticosteroid for treatment of chronic obstructive pulmonary disease, which is a breathing disability. It becomes severe over time and generally smokers are only affected by it.

Valeant Increases its Offer for Salix

Valeant Increases its Offer for Salix

Canadian pharmaceutical major Valeant Pharmaceuticals International has increased its offer for Salix Pharmaceuticals to $10.96 billion in cash.

Valeant concentrates on neurology, dermatology and infectious disease with numerous drugs in late-stage clinical trials and numerous currently on the market. Salix Pharmaceuticals develops drugs and medical devices that prevent and treat many gastrointestinal disorders.

Salix Pharmaceuticals said yes to Valeant's new offer of $173 a share. The price offered is higher compared to $158 per share in cash late last month. According to experts, it would be the largest purchase that Canada-based Valeant ever made. It would be also better for investor Bill Ackman. Ackman made an announcement last week that he had purchased over $3

Kythera Biopharmaceutical’s Drug ATX-101 Very Close to FDA’s approval

Kythera Biopharmaceutical’s Drug ATX-101 Very Close to FDA’s approval

It has been reported that an injection developed by Kythera Biopharmaceutical Inc to get rid of double chin was backed by an independent panel of experts on Monday.

Stock of the biopharmaceutical company has tripled since it went public in 2012. Investors bet that the company's drugs can be the first ever drug approved in the United States to reduce localized fat deposits.

FDA's acceptance of recommendations given by the panel has brought the drug, ATX-101, closer to approval by the agency.

The drug, ATX-101, is a formulation of synthetically derived deoxycholic acid, which helps to destroy the fat that gets collected under the chin. The positive feature about the drug is that it destroys the fats without affecting the surrounding tissues.

Incepta Pharmaceuticals launches generic version of Sovaldi

Incepta Pharmaceuticals launches generic version of Sovaldi

Incepta Pharmaceuticals has brought a generic version of the drug Sovaldi, of the Gilead Sciences, which is being used in treatment of hepatitis C, is a very popular drug. The generic version of the drug will be sold at a price of $10.

The generic drug of Sovaldi is named as Hopetavir and the cost of the drug for a period of 12 weeks will be $900. Cost of Gilead Sciences Inc.'s Sovaldi is very high. "Gilead is aware of unauthorized generic versions of sofosbuvir being offered in the marketplace .We're focused on enabling our eleven Indian generic partners to launch their authorized generic versions as soon as possible", the company said in an e-mail.

So far, it was the most successful drug for treating hepatitis C. And the cost of this drug for a period of twelve weeks was $86,000.

AbbVie to buy leukemia drugmaker Pharmacyclics for $21 billion

AbbVie to buy leukemia drugmaker Pharmacyclics for $21 billion

On Wednesday, pharmaceutical major AbbVie announced that it has entered into a deal worth $21 billion with cancer biotech Pharmacyclics Inc. AbbVie Inc. will buy Pharmacyclics in a cash and stock deal.

The deal, which would be a mix of cash and stock, would allow AbbVie to have its presence in the multibillion-dollar blood-cancer market. Secondly, the deal would reduce AbbVie's dependence on an aging rheumatoid-arthritis drug, which makes most of its sales.

Last year, AbbVie had an agreement worth $54 billion as per which it would buy Irish drug company Shire PLC. But it walked away after the Obama administration increased the strictness level in order to deter such tax-lowering deals.

Johnson & Johnson to sell its Cordis Vascular Technology Unit

Johnson & Johnson to sell its Cordis Vascular Technology Unit

On Monday, United States pharmaceutical and medical equipment maker Johnson & Johnson announced that it will sell its Cordis vascular technology unit to Cardinal Health, health care services company based in Dublin, for $1.99 billion. The deal confirms the pharmaceutical and consumer packaged goods manufacturer's exit from the cardiovascular stent business.

According to reports, the deal consists of $1.944 billion of cash proceeds from Cardinal Health and about $46 million of retained net receivables. Currently, the Fortune 500 health care services company has been expanding its medical equipment offerings for doctors. Net revenue of Cordis in 2014 was about $780 million.

Endo International PLC sells Men’s Health and Prostate Businesses to Boston Scientific

Endo International PLC sells Men’s Health and Prostate Businesses to Boston Scie

On Monday, the pharmaceutical company headquartered in Dublin, Endo International PLC, announced to sell its men’s health and prostate businesses. According to the announcement made by the company, the businesses will be sold to Boston Scientific Corp., manufacturer and marketer of medical devices.

According to the company, it has agreed to sell the businesses for $1.6 billion. While confirming the purchase, Boston Scientific Corp. said that deal value includes additional $50 million in milestone based on 2016 sales.

As per reports, shares of Endo fell less than 1% in premarket trading as the global specialty healthcare company gave quiet guidance for the year. On the other side, after the purchase, shares of Boston Scientific climbed by more than 1%.

Cipla to form JV with Biopharm SPA for respiratory products

Cipla to form JV with Biopharm SPA for respiratory products

New Delhi: Pharmaceutical firm Cipla Ltd has entered into an agreement with Biopharm SPA to form a joint venture company in Algeria to manufacture and market respiratory products, the company said Friday.

In a BSE filing, Cipla said: "A binding term sheet has been entered into with the company's existing partner, Biopharm SPA, for establishing a joint venture (JV) company in Algeria."

"The JV company will manufacture and market respiratory products facilitating Cipla's front-end presence in Algeria," it added.

As per the agreement, Cipla's wholly owned subsidiary, Cipla (EU) Ltd, will hold a 40 percent stake in the JV company while the remainder will be held by a Biopharm-led Algerian consortium.

Pfizer breast cancer drug gets early FDA approval

PfizerWashington: Federal health regulators have approved a highly anticipated medicine from Pfizer Inc to treat postmenopausal women with a certain type of advanced breast cancer who have not already taken other drugs.

The Food and Drug Administration yesterday approved Ibrance for women who have tumors that do not contain a protein known as HER-2. Ibrance, known generically as palbociclib, works by blocking molecules linked to cancer cell growth.

Pharmaceutical industry analysts expect Ibrance to grow into a mega-blockbuster, with annual sales as high as USD 4 billion by 2020.

Sun Pharma gets US FTC clearance for Ranbaxy acquisition

Sun PharmaNew Delhi: The US Federal Trade Commission (FTC) has completed its review of the proposed USD 4 billion acquisition of Ranbaxy Laboratories by Sun Pharma and granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

"The US Federal Trade Commission (FTC) has completed its review of the proposed acquisition of Ranbaxy by Sun Pharma and has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act)," Sun Pharmaceutical Industries and Ranbaxy Laboratories said in a joint statement.

Dr Reddy's Q3 Net declines 7.09% to Rs 574.53 crore

Dr Reddy sNew Delhi: Drug major Dr Reddy's Laboratories on Thursday reported 7.09 per cent decline in its consolidated net profit at Rs 574.53 crore for the quarter ended December 2014.

The company had posted a consolidated net profit of Rs 618.42 crore in the October-December period of the previous financial year, it said in a BSE filing.

However, consolidated net sales rose 8.75 per cent to Rs 3,843.10 crore during the quarter under review as against Rs 3,533.76 crore a year earlier, it added.

Revenue from the global generics segment also grew 7.81 per cent to Rs 3,169.22 crore in the third quarter of FY15. It was Rs 2,939.58 crore in the same period of previous fiscal.

Sun Pharma chief expects Ranbaxy deal to be closed by mid-Feb

Sun PharmaHyderabad: Drug major Sun Pharma's top executive Dilip S Shanghvi expects the USD 4-billion Ranbaxy deal to be concluded by middle of next month while stating that the key challenge before the combined entity would be to rebuild the confidence of health regulators.

"I think Punjab and Haryana High Court will hear the issue of merger on February 2. Once we get the approval (from the court), then it will take a few more days. We need to meet certain company laws. So, hopefully by middle of February we should be able to close the deal," Sun Pharma Managing Director Dilip S Shanghvi told reporters here.

German regulator hails EMA's drugs suspension on GVK Bio data

Berlin - German drug regulator has welcomed the European Medicine Agency's (EMA) decision to suspend the marketing authorisation of around 700 generic drugs subjected to clinical trials by India's GVK Biosciences.

The move is being seen as the EU's determination to maintain high ethical and medical standards for approval of medicines.

The EU drug regulator's announcement is also an endorsement of the Federal Institute for Drugs and Medical Devices' (BfArM) decision last month to ban the sale of 80 generic drugs on account of "substantial deficiencies" in clinical trials conducted by GVK Biosciences, the agency said in a statement.

Sanofi launches Shan5 paediatric pentavalent vaccine

Hyderabad - Sanofi Pasteur Monday announced the launch of its paediatric pentavalent vaccine Shan5, developed and manufactured by its affiliate Shantha here.

Shantha, a fully integrated biotechnology company involved in R and D, manufacturing and marketing, was acquired by Sanofi Pasteur Holding in 2009.

Shan5 is a fully liquid five-in-one convenient, safe and high quality vaccine that provides effective protection to children from six weeks of age against five diseases - diphtheria, tetanus, pertussis, Hib and hepatitis B.

The launch of Shan5 vaccine received prequalification status from the World Health Organisation (WHO) in April 2014, a press release from Sanofi said.

Ranbaxy posts Q2 net profit of Rs 477.75 cr

New Delhi - Drug firm Ranbaxy Laboratories Tuesday reported a consolidated net profit of Rs 477.75 crore for the quarter ended September 30, 2014 on account of robust sales.

The company had posted a net loss after tax, minority interest and share in loss of associates of Rs 454.16 crore for the corresponding period of the previous fiscal, Ranbaxy Laboratories said in a filing to BSE.

Consolidated net sales of the company stood at Rs 3,218 crore for the quarter under consideration as against Rs 2,750.17 crore for the same period year ago, it added.

Ranbaxy to pay $40 million to settle Texas litigation

Ranbaxy Laboratories_Mumbai: Generic drugmaker Ranbaxy Laboratories Ltd said it had agreed to pay $39.75 million to settle litigations concerning its participation in Texas Medicaid, the US federal-state healthcare program for the poor.

The payments will be made in tranches through August 2015, Ranbaxy informed the BSE on Thursday.

"The claims at issue related exclusively to the manner in which Ranbaxy has historically reported pricing data to Texas Medicaid for certain of its drugs," the company said in the statement.

Ranbaxy shares were up 0.7 percent at 602.10 rupees at 9:47 a. m. in Mumbai, while the broader Nifty was up 0.14 percent on Thursday.--PTI




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