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GSK HIV 2-drug regimen found effective; FDA issues guidelines on drug prices

Top news

* GlaxoSmithKline PLC unit ViiV Healthcare Ltd. said results from two late-stage studies showed its two-drug regimen for untreated HIV patients was just as effective as taking three drugs. The studies evaluated a combination of dolutegravir and lamivudine against the standard-of-care three-drug regimen of dolutegravir and tenofovir disoproxil fumarate/emtricitabine, in HIV-infected adult patients who did not get any anti-retroviral treatment.

* U.S. Food and Drug Administration Commissioner Scott Gottlieb issued a set of three new guidelines for drugmakers aimed at supporting better price negotiations, driving competition and securing reimbursement.

The new guidelines — Drug and Device Manufacturer Communications With Payers, Formulary Committees and Similar Entities; and Medical Product Communications That Are Consistent With the FDA-Required Labeling — are intended to make it easier for drug manufacturers and device makers to more freely discuss with payers and providers reliable scientific and economic information about unapproved uses of medical products and data not included in the labeling of therapies cleared for the U.S. market.

In issuing a third set of guidelines on June 12 — Limited Population Pathway for Antibacterial and Antifungal Drugs — Gottlieb promoted the idea of moving to a reimbursement model in which hospitals would pay a fixed licensing fee for access to antibiotics restricted for use in patients infected with the most dangerous multidrug-resistant pathogens.

On the policy front

* EU member states supported a plan to fight antimicrobial resistance, Reuters reported. The new rules would prevent the abuse of antibiotics, limiting the preventive use of these drugs for animals that are not sick and limiting certain therapies to their treatment of humans.

* The U.K. government will welcome more non-EU doctors and nurses, excluding them from the annual visa cap that limits the number of foreign workers in Britain, BBC News reported.

* Bulgaria reported an outbreak of a virulent bird flu virus in a farm in the country's northeastern region, following an earlier outbreak of the virus on a separate duck farm, Reuters wrote, citing the Bulgarian Food Safety Agency.

M&A and capital markets

* Medical device company Sirtex Medical Ltd.'s board recommended an offer from China Grand Pharmaceutical and Healthcare Holdings Ltd. and CDH Investments to acquire it for A$33.60 per share in cash, or about A$1.9 billion. Australia-based Sirtex is choosing the Chinese consortium over Palo Alto, Calif.-based Varian Medical Systems Inc., which had earlier agreed to take over the company for about A$1.59 billion.

* Recipharm AB is acquiring Sanofi's contract manufacturing business in the U.K. for £45 million in a bid to expand its capabilities in the inhalation drug market.

* Madrigal Pharmaceuticals Inc. is considering a sale of the company, Bloomberg News reported June 13, citing anonymous sources. The Pennsylvania-based company received takeover interest from companies looking for therapies for a liver disease known as nonalcoholic steatohepatitis, or NASH.

Drug and product pipeline

* The U.S. FDA has found minor deficiencies in Mylan NV's application for a generic version of GlaxoSmithKline's blockbuster asthma treatment Advair Diskus. Mylan said it expects the regulator to issue a complete response letter identifying the issues June 27.

* Biogen Inc. and Samsung Bioepis Co. Ltd. said an analysis of results from three studies showed that their biosimilar medicines Benepali, Flixabi and Imraldi were as effective as their brand-name counterparts in patients with rheumatoid arthritis. The phase 3 studies compared Benepali to etanercept, sold by Amgen Inc. as Enbrel; Flixabi to infliximab, sold by Johnson & Johnson as Remicade; and Imraldi to adalimumab, sold by AbbVie Inc. as Humira.

* Flex Pharma Inc. is ending its phase 2 study to treat two degenerative disorders after concerns that patients could not tolerate three daily doses of its experimental pill. The Boston-based biotech also said it will slash its workforce by 60% in the coming weeks, with most of its restructuring measures announced by June 30.

* The FDA rejected scPharmaceuticals Inc.'s application to market Furoscix, a potential therapy for edema, or an abnormal accumulation of fluid in the body, in people with heart failure. The company received a complete response letter from the agency indicating that scPharmaceuticals needs to consider device modifications and conduct additional research, potentially including a validation study in people.

* The FDA approved a combination of Roche Holding AG's blockbuster medicine Avastin and chemotherapy for treating women with advanced ovarian cancer who had undergone surgery.

* Roche said its drug Ocrevus may delay the need for a wheelchair for patients with a type of multiple sclerosis — a disease of the central nervous system.

Our features

Gene therapy group gears up for education campaign as CRISPR anxiety grows: A recent study linking gene-editing tool CRISPR to cancer comes just as industry groups ramp up efforts to reach consumers and physicians.

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Medical marijuana stocks on a high as legislation could pave way for greater use: The medical marijuana industry has seen rapid growth as the prospects for further legalization improve and investors fund innovators looking at expanding the use of cannabis, with the market expected to more than double in size by 2022.

Other features

* Sanofi is preparing for its comeback in the cancer field after a seven-year hiatus with a new antitumor therapy it is developing with Regeneron Pharmaceuticals Inc., targeted for launch by year-end, Bloomberg News reported, citing Joanne Lager, head of oncology development at the Paris-based biopharmaceutical company.

* Sanofi is holding on to its Dengvaxia dengue vaccine, even after reports that the shot could pose risks to children who have never experienced the mosquito-borne disease — but a diagnostic test that would determine if a child has previously suffered from dengue has yet to be discovered, STAT wrote.

* Chinese women traveling to Hong Kong to get vaccinated against human papillomavirus, or HPV — which can cause cervical cancer — has drained supplies of Merck & Co. Inc.'s Gardasil 9 in Hong Kong since it became available two years ago, Bloomberg reported.

The day ahead

Early morning futures indicators pointed to a mixed opening for the U.S. market.

In Asia, the Hang Seng was down 0.93% to 30,440.17, while the Nikkei 225 fell 0.99% to 22,738.61.

In Europe, around midday, the FTSE 100 fell 0.47% to 7,667.60, and the Euronext 100 was down 0.45% to 1,058.74.

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