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India’s antitrust regulator cleared Sun Pharmaceutical Industries Ltd. (SUNP)’s $5.3 billion proposal to buy Ranbaxy Laboratories Ltd. (RBXY) contingent on the companies selling some overlapping brands.

The Competition Commission of India ordered Sun and Ranbaxy to sell seven brands in which the merged company would have “appreciable adverse effect” on domestic competition as a result of market share, the commission said on its website yesterday.

Read more – Bloomberg

Days after European Union health officials suspected wrongdoing by contract research and clinical trials firm GVK Bio, the company was faced with several clients threatening to cancel contracts and some contemplating penal action, said chief executive Manni Kantipudi.

Read more – The Economic Times

Sarah Boseley reports from Sierra Leone, where a call to the hotline can mean you are taken away to a treatment centre and may never see your family again…

Read more – The Guardian

Global efforts have halved the number of people dying from malaria – a tremendous achievement, the World Health Organization says.

It says between 2001 and 2013, 4.3 million deaths were averted, 3.9 million of which were children under the age of five in sub-Saharan Africa.

Each year, more people are being reached with life-saving malaria interventions, the WHO says.

Read more – BBC News

Drug maker Cadila Healthcare Ltd said on Tuesday it launched in India the first biosimilar version of the anti-inflammatory medicine adalimumab, the world’s top-selling drug, at a fifth of its US price.

The drug’s branded version is sold under the name Humira by US firm AbbVie Inc, and costs $1,000 for a vial in the United States. Humira had sales of $3.26 billion in the quarter ended September, accounting for 65 per cent of AbbVie’s total revenue.

A price of $200 a vial would still keep the drug out of reach for most people in India, where more than 70 per cent of the population lives on less than $2 a day and health insurance is scarce.

Read more – NDTVProfit.com

The World Health Organization reported steep declines in malaria cases and deaths compared with 2000 in a report released early Tuesday, saying the progress was particularly notable in Africa, where the disease is most prevalent.

Read more – NYTimes.com

A real healthcare crisis has been in the works for the last half-century and it has nothing to do with the cost of healthcare, although you could argue it has something to do with the price of it. It has everything to do with the phenomenon of antibiotic drug resistance. Some of the best investment strategies begin with identifying an important need and filling that need. In biotech and healthcare investing, identifying crucial needs is often linked to matters of life and death, and with regard to Cubist, Merck may have hit the proverbial jackpot in the field of antibiotics and drug resistance.

Read more – Forbes

Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.

Bharat Shah, founder of Sigma, which imports medicines into the UK, said generic shortages have “become a nightmare in the UK,” causing “suffering” to patients.

In the last two years India has seen “a lot of issues with GMP compliances, especially for Europe and the US,” he said at the UBM India Pharma Awards in Mumbai last week during CPHI India.

Read more – in-Pharmatechnologist.com

Foreign pharmaceutical companies in China say they are concerned that recent regulatory delays could push back plans to introduce their newest medicines into the country by as many as two years.

At least thirty-four applications from foreign multinationals have been or are set to be delayed after Chinese regulators began requiring an added procedure, according to R&D-Based Pharmaceutical Association Committee, an industry group.

Read more – Bloomberg

The fortunes of Indian drug makers are largely dependent on the generic medicines they make for the US market. But with consolidation in the US pharmaceutical supply chain hurting the earnings of Indian drug makers, at least one of them is trying to break the mould and become an innovator.

Hyderabad-based Dr Reddy’s Laboratories (DRL) is looking to move up the value chain and is planning to file two NDAs (new drug applications) with the US Food and Drugs Administration (USFDA) by the end of 2015. The two products that the company is indigenously developing are for the treatment of dermatological and neurological ailments respectively.

Read more – The Financial Express

Federal prosecutors in Indianapolis dropped all charges against two scientists accused of stealing trade secrets worth $55 million from Eli Lilly and Co., according to a court motion made Friday in federal court in Indianapolis.

The case against former Lilly scientists Guoqing Cao and Shuyu Li collapsed less than a month after Indianapolis-based Lilly provided “additional information” to the U.S. Department of Justice that changed “the investigative facts initially relied upon by the government” in its case against the two men, according to court documents.

It was not clear what that additional information was.

Read more – IBJ.com

The company had taken a Rs 60-crore hit as new orders from the clients were stopped from August

Hyderabad-based contract research organisation GVK Biosciences on Monday said the company was ready to re-do all the clinical studies of drugs over which the European Medicines Agency (EMA) raised an alarm citing the findings of French drug regulatory agency, ANSM.

Read more – Business Standard News

The long-pending $4-billion merger between Sun Pharma and Ranbaxy today got a conditional approval from fair trade watchdog CCI, which asked the two companies to divest some key products along with other changes to the deal to address the anti-competitive issues.

The fair trade regulator’s approval comes after the first ever public scrutiny carried out by it for a merger, which was announced in April and would create India’s largest and world’s fifth biggest drug-maker.

Read more – The Economic Times

Merck ($MRK) is shelling out $9.5 billion for antibiotics specialist Cubist Pharmaceuticals ($CBST), joining the wave of major drugmakers with a renewed interest in anti-invectives.

Under the deal, Merck will hand over $102 in cash for each Cubist share, a 35% premium to the company’s average stock price last week. That gives Cubist an equity value of $8.4 billion, and Merck is signing up to cover another $1.1 billion in debt, expecting to close the acquisition in the first quarter of next year.

Read more – FierceBiotech

Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.

Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered “irregularities” in documents relating to human studies conducted by GVK Bio in Hyderabad.”

This decision is taken as a precaution. No element at this stage has led to establish a true risk to human health or a lack of efficacy of these drugs,” France’s National Agency for Medication Safety and Health Products, or ANSM, said on its website.

Read more – The Telegraph (Calcutta)