January 17, 2017

The publication of the draft guidance means that stakeholders can now comment for 60 days after Jan. 18 in order for comments to be considered before the final version of the guidance is written

January 11, 2017

Mayne Pharma acquired the products from GSK in August 2016, and they complement the company’s Doryx, the first branded product in its specialty brands division that it launched in 2015. 

January 9, 2017
Under the agreement, ImmuNext will grant Sanofi and exclusive worldwide license to develop and commercialize INX-021, a monoclonal antibody in preclinical development that suppresses the activity of a cellular pathway that’s overactive in many autoimmune diseases.
January 6, 2017

The number of drugs the FDA approved last year, 22, is less than half of the 45 approved in 2015 and lower than the average of the last 10 years of approvals, which is 29. 

January 6, 2017
This is the fifth approved indication for Lucentis. 
January 5, 2017

Rebecca Shanahan and Mike Agostino took new roles on Jan. 1, respectively. 

January 5, 2017

Merger to create a clinical-stage company focused on clinical and commercial development of cytisine, a selective nicotine receptor partial agonist currently in late-stage development for smoking cessation.  

January 3, 2017
Forbes is reporting that the Food and Drug Administration’s approval of 22 new drugs in 2016 (down from 51 in 2015) could have big implications for the future of innovation in the pharmaceutical space. The report notes that research spending is growing, but there are practical difficulties to translate innovation into products as R&D returns decline  — and the report suggests overcoming that difficulty could mean rethinking a lot. (Forbes)
 
December 19, 2016

Approval for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation.

December 15, 2016

The drug’s availability comes a year after the Food and Drug Administration approved it as a follow-on biologic to Lantus, another U-100 long-acting insulin. It has an amino acid sequence identical to that of Lantus. 

December 13, 2016

The act will invest more than $6 billion over seven years to provide funding for various initiatives, including fighting prescription drug abuse, expanding the president’s Precision Medication Initiative and funding the “cancer moonshot,” aimed at finding new and better treatments for cancer.

December 9, 2016

The results come from an employee survey administered by research firm WorkplaceDynamics. The survey measured such aspects of workplace culture as alignment, execution and connection. T

December 7, 2016

President Obama said in his Dec. 3 weekly address that he would sign the legislation into law "as soon as it reaches my desk."

December 7, 2016

In an interview with Time published Tuesday morning to accompany his being chosen as the magazine’s “Person of the Year,” President-elect Donald Trump told the magazine that one of his goals as president is lowering the cost of prescription drugs.  

December 7, 2016

The brand unites American Homecare Federation, At-Home IV Infusion Professional, BioRx, MedPro Rx and XAS infusion services under Diplomat Specialty Infusion Group. 

December 7, 2016

The certification was awarded by both the Utilization Review Accreditation Commission (URAC) and the Accreditation Commission for Health Care (ACHC), both national nonprofit standards organizations.

December 5, 2016

In an effort to contain costs and both improve and expand care, pharmacists will more and more play an integral role in healthcare, as illustrated by these five key trends identified by McKesson analysts.

December 2, 2016

The score Amber Pharmacy earned a score of 74 on a 100-point scale that looks at the likelihood patients will recommend their pharmacy to someone else — the second-highest score of all 38 specialty pharmacies assessed by Zitter Health Insights.

December 2, 2016

The drug was approved by the Food and Drug Administration to treat multiple myeloma in patients who have received at least one other treatment.

November 29, 2016

Walgreens opened the doors to its latest specialty pharmacy in the Columbus, Ohio market, Columbus Business First reported Tuesday. "With the brand name 'Community, A Walgreens Pharmacy,' the facility opened this week at 114 W. 3rd Ave., in an office building next to Select Specialty Hospital, which provides short-term rehabilitation stays after hospitalization for surgery, stroke and other reasons," Columbus Business reported. To date, Walgreens has more than 250 pharmacies operating under the Community banner, the report added. (Columbus Business First)

November 28, 2016

Both companies have confirmed that they are in preliminary discussions. 

November 21, 2016

Diplomat has begun dispensing Shire’s recently launched primary immunodeficiency treatment. 

November 17, 2016

The new Phoenix headquarters includes an 8,000-square-foot clean room that is nearly three times the space available at Avella’s previous location.

November 17, 2016

A new survey from InCrowd found that 84% of surveyed physicians in dermatology, endocrinology, gastroenterology, oncology and rheumatology said they expect to prescribe, will prescribe or look forward to prescribing more biosimilars in the coming three years.