FDA Explores Flexible Drug Marketing Policies

JILL WECHSLER | November 1, 2017

article image
FDA regulation of prescription drug and medical product promotion has come under fire in recent years, as federal courts have supported industry challenges to rules limiting communications of unapproved drug uses.

Spotlight

Alina Combine Pharmaceuticals Pvt. Ltd.

Alina Combine Pharmaceuticals (Pvt) Ltd is one of Pakistan's premier Pharmaceutical & Veterinary Medicine manufacturing company following strict GMP guidelines. Our pharmaceutical manufacturing unit is well equipped and manned by highly qualified and experienced personnel. Our current range of products includes Water Soluble Powders, Liquids/Solutions, Liquid Injections in the Veterinary Department and a range of Human Pharmaceuticals in the form of Liquids, Tablets, Ointments, and Injections.

OTHER ARTICLES

Pricing of drugs – at what cost?

Article | February 27, 2020

We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.

Read More

What to Watch in 2020: Non-Specialty Drugs

Article | February 27, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

Read More

How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | February 27, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

Read More

As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | February 27, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

Read More

Spotlight

Alina Combine Pharmaceuticals Pvt. Ltd.

Alina Combine Pharmaceuticals (Pvt) Ltd is one of Pakistan's premier Pharmaceutical & Veterinary Medicine manufacturing company following strict GMP guidelines. Our pharmaceutical manufacturing unit is well equipped and manned by highly qualified and experienced personnel. Our current range of products includes Water Soluble Powders, Liquids/Solutions, Liquid Injections in the Veterinary Department and a range of Human Pharmaceuticals in the form of Liquids, Tablets, Ointments, and Injections.

Events