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USFDA has now issued the draft regulations to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product including both a drug and a delivery device.
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Just a few days before Trump took his oath, he said the pharmaceutical industry getting away with murder in the way it sells medicine, and he promised to take the industry. It was a promise he made several times on the election campaign.
Pharmaceutical companies could be forgiven if they are confused about whether President Trump thinks the government should get involved in negotiating the price of prescription drugs for Medicare patients.
But last week, Trump appeared to walk that vow back when he met with the leaders of several giant pharmaceutical companies at the White House.
When asked during his daily news briefing whether the president is in favor of having Medicare negotiate lower prices for prescription medicine, Spicer said: "He's for it, yes. Absolutely."
"We're the largest buyer of drugs in the world and yet we don't bid properly," he said at a news conference in early January. "We're going to start bidding and we're going to save billions of dollars over a period of time."
"I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing a product to a vibrantly competitive market," he said, sitting around a table in the Roosevelt Room, flanked by leaders of five large drugmakers. "That includes price fixing by the biggest dog in the market Medicare which is what's happening."
"So his commitment is to make sure that he does what he can," Spicer said, "and, I think rather successfully, use his skills as a businessman to drive them down."
The Medicare prescription drug program was created in 2003; the program's drug coverage is handled exclusively by Private insurance company. There is no direct government pharmacy coverage. Current U.S. law prohibits Medicare officials from interfering in the negotiations between drugmakers and the insurance companies that administer Medicare's prescription drug plans.
Medicare accounts for about 29 percent of all spending on prescription medicines in the U.S. each year. So, would bringing Medicare's huge purchasing power to bear in talks over prescription drug prices actually reduce those prices?
The only government report that looks at the issue is a 2007 Congressional Budget Office study that concluded that it would have a "negligible effect" on prices.
Dr. Wallid Gelad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, disagrees."There's a reason why the pharmaceutical industry does not want Medicare negotiation to happen," Gellad told NPR. "And the obvious reason is because it will lower prices." Gellad said the CBO report doesn't take into account the ability the government would have to say no to some particularly high-priced medicines.
"If Medicare were to get the same prices for drugs as in the VA you'd have billions, tens of billions of dollars of savings," Gellad told NPR.
The government has approved the signing of an agreement between India and Senegal in the field of health and medicine. The agreement includes cooperation in the fight against AIDS, integrated disease surveillance and emergency relief.
Recognizing India's "major defense partner", the United States has made the necessary changes to its export control laws that would benefit India by facilitating the transfer of technology and weapons.
The Department of Pharmaceuticals (DoP) has rejected the review application filed by FDC Ltd against price fixation of “Metformin (1000 mg), flunarizine, ramipril etc.”
A senior Commerce and industry ministry official said that Indian pharma exports in the current financial year may see a near double-digit growth and might end up on the lines with that of last year.
A study led by the University of Warwick has found a link between the removal of ovaries during hysterectomy and an increase in heart disease, cancer and premature death.
Researchers at the University of Southampton have developed a new 3D system to study human infection in the laboratory. The team, which includes infection researchers, engineers and bioinformaticians in Southampton and at University College London, have used an electrostatic encapsulation technique to make tiny 3D spheres within which human cells are infected with tuberculosis (TB) bacteria to generate conditions that more closely reflect events in patients.
UK biotech company Nemaura Pharma has announced a commitment from private investors of up to £5m for the development of a hormone Biologic using its Micro-Patch™ solid dose delivery platform. The fast-growing company has made significant progress in the reformulation of liquid vaccines administered through the skin using its solid dose delivery system. The funding is being used to accelerate Nemaura’s commercial research and development of clinical programmes to prepare the drug-device combination for market.
Arbutus Biopharma Corporation an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus (HBV) infection, announced that the Supreme Court of British Columbia granted Arbutus’ request for a pre-trial injunction against Acuitas, preventing Acuitas from sublicensing Arbutus’ lipid nanoparticle (LNP) technology until the end of October, or further order of the Court. Under the terms of the pre-trial injunction, Acuitas is prevented from entering into any new agreements which include sublicensing of Arbutus’ LNP.
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