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    Divi’s Labs on FDA’s Import Alert List; but did it refuse an inspection?

    Divi’s Labs on FDA’s Import Alert List; but did it refuse an inspection?

    Divi's Laboratories — an Indian active pharmaceutical ingredient (API) manufacturer and until recently the darling of the Indian bourses — received another setback this week.  The US Food and Drug Administration (FDA) placed its Unit II, located in Visakhapatnam, on its import alert list for “refusing FDA foreign establishment inspection” as also for “not meeting drug GMPs” (good manufacturing practices). According to the FDA website “the refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.” The firm is considered to have refused the FDA inspection. This news comes as a surprise, as it adds an additional dimension to the problems that the FDA encountered at Divi’s facilities.  PharmaCompass had previously shared news that Health Canada had placed the company on its inspection tracker after data integrity and general GMP observations were reported by its “regulatory partner(s)”.  According to media reports, the firm was inspected by the US FDA from November 29 to December 6, 2016, and the regulators had issued an 18-page long Form 483 with five observations. Second Divi’s group firm to refuse inspection   The news comes a few months after its affiliate – Divi’s Pharmaceutical Private Ltd was placed on FDA’s Import Alert List for refusing an inspection by the US FDA. The two facilities of Divi’s Pharmaceutical  that were placed on the FDA’s Red List were Divi Towers in Hyderabad, and a facility in Medak district, Telangana. Divi Towers is also the corporate headquarters of Divi’s Laboratories. Divi’s Laboratories’ Unit-II is a major producer of APIs and a key supplier to leading companies around the world. The FDA has excluded some intermediates and the following APIs from the import alerts – Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium , Raltegravir potassium and Atovaquone.  The exemptions did not help as far as the stock market was concerned. Divi’s stock price, which has already been under significant pressure after news of the inspection initially broke out in December, tanked another 20 percent on Tuesday. Our view   While the details are yet to emerge on the exact nature of problems which the US FDA inspectors uncovered and encountered at Divi’s Laboratories Unit II, it is clear that Divi’s has a long road ahead insofar as regulatory compliance is concerned.

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    https://www.pharmacompass.com/radio-compass-blog/divi-s-labs-on-fda-s-import-alert-list-but-did-it-refuse-an-inspection

    #Phispers by PHARMACOMPASS
    23 Mar 2017
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    Did Abbott’s sales rep kill himself due to work pressure? Clinton’s VP nominee under scrutiny for receiving favors from Teva’s Barr

    Did Abbott’s sales rep kill himself due to work pressure? Clinton’s VP nominee under scrutiny for receiving favors from Teva’s Barr

    This week, Phispers brings you the latest on controversies, such as the one surrounding Hillary Clinton’s running mate Tim Kaine and Roche’s Avastin that caused vision damage in patients at an Indian hospital. There is also regulatory news from across the world, and the latest M&A deal. Did Abbott’s sales rep in India kill himself due to pressure to meet targets? An Abbott medical representative in India killed himself last week, allegedly due to the pressure put by the pharma company to achieve periodic sales targets. As per a news report, Ashish Awasthi, 35, was found dead on a railway track, with a note that blamed the company for his death. Abbott, however, has denied any role in his death. In fact, the company has said Awasthi was rated among the top performers and had recently qualified for a training certification meant for high performers. Roche’s Avastin sent for testing, as stakeholders play blame-game in vision damage caseIndia’s Health Ministry has sent samples of Roche’s Avastin for testing following reports that 27 out of 30 patients at the Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, complained of infection and vision damage after being administered the drug.Samples of the drug used were sent to Central Drugs Laboratory in Kolkata for testing. The cause of the problem remains unclear, though the patients have been discharged from the hospital.  PGIMER suspects the problem was an outcome of the local chemist supplying spurious drugs. This is the first time in nine years that the hospital has purchased the medicine from a chemist, as this time there was a delay in supply from Roche. The chemist, in turn, passed the buck onto Roche.In a statement, Roche blamed the doctors, and said they should not have administered the drug. “The safety of patients is always our priority and we are treating the event in Chandigarh relating to the off-label use of Avastin (bevacizumab) in the eye very seriously. Avastin is an important cancer therapy... We would like to reiterate that [it] has not been approved for use in the eye by the US FDA (Federal Drug Administration), EMA (European Medicines Agency) or the Government of India,” Roche said. Clinton’s VP nominee under scrutiny for receiving favours from Teva’s BarrWhen it comes to accepting gifts from pharmaceutical companies, doctors have invariably been the target of scrutiny. However, last week America’s presidential candidate Hillary Clinton’s running mate – Senator Tim Kaine – received much bad press for accepting a pharma company’s offer to fly him on a private jet to a meeting in Aspen. The company – Barr Pharmaceutical (now a part of Teva) – flew Clinton’s pick for the US vice president in a private jet, and the flight was worth US $ 12,000, says Kaine’s disclosure report. Kaine was then the governor of Virginia. And Barr executives were lobbying Kaine to write a letter to the FDA on its behalf. Kaine signed a letter to US regulators – as requested by Barr – before taking the flight, say reports.However, other news reports point that the flight and other gifts (worth US $ 160,000) Kaine accepted during his stint as governor were legal under Virginia’s laws at the time, since they were disclosed. FDA rejects Valeant’s potential blockbuster drug for treating glaucomaLast week, Valeant’s experimental glaucoma drug was rejected by the FDA, due to manufacturing practices at its Florida facility. In a statement, Valeant said it had received a Complete Response Letter from the FDA regarding its New Drug Application for Vesneo (latanoprostene bunod) – an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. In its rejection letter, the FDA did not cite concerns over efficacy or safety of the drug, but raised unspecified deficiencies at the Florida plant operated by Valeant’s Bausch & Lomb division. If approved, Vesneo will be the first nitric oxide donating prostaglandin receptor agonist available for the two disorders. Some analysts have suggested the drug (when approved) could become a global blockbuster with more than US $ 1 billion in annual sales. FDA approves record number of generic drug applications from IndiaAll news pertaining to Indian pharma may sound negative. But that’s not true – several new players are winning approvals to sell generics in the US market. Thought the FDA has stepped up both scrutiny and regulatory action against drug companies in India, it’s also been approving generic drug applications from India at a frenetic pace.For instance, Sun Pharma, Glenmark and Aurobindo said they had received approval to sell generics of the AstraZeneca’s blockbuster cholesterol pill Crestor in the US.During July to December 2015, the FDA approved a record 83 new generic drug applications out of India’s publicly listed firms. And during January to June 2016, though the pace of approvals slowed down to 73, it is still amongst the best six-months in statistics for approvals going back to 2005. An off-patent malaria drug may help treat cancerAn off-patent malaria drug – Atovaquone – has been found to boost oxygen levels in the tumour cells in mice. This makes radiotherapy more effective in treating a range of cancer, including cancer of the lung, bowel, brain and head and neck. The drug is known to be safe.Cancer cells with low oxygen levels are more difficult to treat with radiotherapy, and are more likely to spread to other parts of the body. Early work undertaken by British scientists points that Atovaquone could help destroy cancer cells by making them more susceptible to radiotherapy. This has prompted the scientists to start clinical trial on the off-patent drug. China likely to be first off-the-block to use CRISPR-Cas9 genome editing tool A long-standing goal of biomedical research is the development of an efficient and reliable way to make precise and targeted changes to the genome of living cells. Clustered regularly interspaced short palindromic repeats (CRISPR) are segments of prokaryotic DNA containing short repetitions of base sequences. And CRISPR-Cas9 – a new tool in genome editing – has created considerable excitement in biomedical research.However, it’s not the Americans who will be the first to use this tool. Scientists in China plan to use CRISPR-Cas9 in patients as early as next month. If they go ahead, it would be the first time people would be injected with cells whose DNA has been altered.A US proposal to run a similar study received approval by a federal ethics and safety panel last month, but it faces months of additional regulatory hurdles. And the earliest it can go ahead is 2016-end.Scientists intend to use CRISPR to edit immune-system T cells in patients with cancer in an effort to make those cells destroy malignant cells. Novartis AG stops making TB drugs in Pakistan due to dispute over pricingPakistan has the world’s fifth-largest incidence of tuberculosis. And fears of a health crisis – triggered by the shortage of TB drugs – looms over the country, as Novartis AG said it has stopped making TB drugs in Pakistan due to a dispute over pricing. The Drug Regulatory Authority of Pakistan (DRAP) sets prices for about 320 critical medicines. But pricing caps have not been significantly raised since 2001, and drug companies find it unviable to make several drugs in the country. This news comes at a time when Novartis is bracing up for a tougher price environment in the US, post the presidential elections. This imminent pricing environment is likely to compel the global pharmaceutical industry to restructure. China’s Fosun to buy Gland Pharma for US $ 1.4 billionThis week, Shanghai Fosun Pharmaceutical (Group) signed a definitive agreement to acquire controlling stake in Hyderabad-based Gland Pharma in a US $ 1.4 billion deal. This is the first instance of a large FDI coming into India’s manufacturing sector from China. It also paves the way for Fosun to expand its research and manufacturing capacity in India.By way of this agreement, Fosun will acquire 86 percent stake in the company, by buying shares held by founders Ravi Penmetsa and family and private equity giant KKR & Company LP. KKR had bought 38 percent in Gland in November 2013, for about US $ 191 million, valuing the company at US $ 600-650 million at the time. 

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    https://www.pharmacompass.com/radio-compass-blog/did-abbott-s-sales-rep-kill-himself-due-to-work-pressure-clinton-s-vp-nominee-under-scrutiny-for-receiving-favors-from-teva-s-barr

    #Phispers by PHARMACOMPASS
    28 Jul 2016
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