FDA

  • FDA Issues Revised ICH Risk-Benefit Submission Guidance
The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions.  Read More
  • FDA Publishes Over 30 New and Revised Product-Specific Draft Guidance
The new guidance include recommendations for developing generics for aspirin and its combination with the heartburn medication Prilosec (omeprazole) - in addition to therapies for schizophrenia, epilepsy and colorectal cancer, as well as antibiotics and a topical corticosteroid. They also include antivirals and combinations for HIV and hepatitis C.  Read More

MERGER and ACQUISITION
  • Novartis CEO says shopping for bolt-ons is tough. Why? Creeping biotech deal prices
Jimenez said Tuesday that Novartis is "still very focused on our strategy of bolt-on acquisitions anywhere from $2 billion to $5 billion," but added that the company is having a hard time finding value in that size range.  Read More
  • With its 5.3B Euro buyout scuppered, Stada brings in new CEO, CFO
A former Boehringer Ingelheim exec, Engelbert Coster Tjeenk Willink will serve as interim CEO, Stada said on Tuesday. The company tapped Bernhard Duttmann, who has served as CFO at chemicals firm Lanxess and skin care company Beiersdorf, for its top financial post on an interim basis.  Read More

FINANCIAL
  • Gilead's hepatitis C franchise breaks out of a rut, but the M&A drumbeat continues
The hep C franchise, which recently won a new addition in Vosevi, came in at $2.86 billion, beating analysts' consensus expectations by $567 million, according to a note from Jefferies. HIV drugs also delivered strong sales of $3.57 billion.   Read More
  • AbbVie scores surprisingly good Q2 results but pipeline worries persist
That's because the Illinois pharma can't escape the burden presented by rheumatoid arthritis treatment Humira, which accounts for 60% of its sales and is the world's top-selling drug. Sales of the drug rose 14% year-over-year during the quarter to $4.7 billion, beating analysts' expectations, but the company itself has predicted that biosimilar competition will start taking a toll on sales next year. That has left investors desperate for signs of anything coming out of the company's pipeline that will help make up for the impending loss.   Read More

CLINICAL RESEARCH
  • WHO urges action against HIV drug resistance threat
The WHO HIV drug resistance report 2017 shows that in 6 of the 11 countries surveyed in Africa, Asia and Latin America, over 10% of people starting antiretroviral therapy had a strain of HIV that was resistant to some of the most widely used HIV medicines. Once the threshold of 10% has been reached, WHO recommends those countries urgently review their HIV treatment programmes.   Read More
  • EMA revises guideline on first-in-human clinical trials
First-in-human trials are a key step in medicines development, where a medicine already tested in vitro, in animals or in other preclinical studies is administered to people for the first time.   Read More

INDIAN PHARMA
  • Anti-Dumping Duty Likely On A Chinese Import Used By Indian Pharma Companies
The government may impose an anti-dumping duty of $72.95 per tonne on imports of a chemical from China, used in pharmaceutical and other industries.  Read More
  • India: Mergers, Acquisitions And Joint Venture: Trends In Bio-Similar Industries
Mergers, acquisitions and joint ventures (M&As) amongst businesses are well known trends and often considered critical for the growth of a company. Additionally, M&As help to strengthen and explore market opportunities, functional and financial synergy along with ability to generate additional revenues.  Read More

VEEDA NEWS

  • United States Food and Drug Administration (USFDA) conducted 8 site Inspection of Patient based PK studies managed by Veeda Clinical Research in 2016-17.
Veeda CR is glad to share the successful completion of 8 USFDA Inspection at Clinical trial sites for various studies managed by Veeda CR in last financial year -2016-17. The studies were conducted in various indications like Chronic Myeloid Leukemia / GIST, Psoriasis, Rheumatoid arthritis, Advanced Rental cell Carcinoma and Breast Cancer. The Outcome of all the 8 USFDA Inspection in a year was -No 483s,which accounts for a total of 10 out of 11 USFDA Inspections at clinical trials sites with No 483s.   Read More
  • Achievement of VEEDA on D-Penicillamine - The lifesaving drug.
FDA some time back released a list which includes drug for' Wilson's disease treatment named penicillamine which lacks the generic competition. The availability of the drug is very important as there are no alternatives for the treatment of Wilson's disease.  Read More

August Disease Focus

  • Sleep Disorders State Management
In order to prepare your pharmacy for Sleep Awareness week, which occurs the first week of March, a quick review of sleep disorders, prevalence, and treatment options is a great place to begin. "Sleep disorders" is a generalized term for over 70 different disorders that generally fall into the following three categories: lack of sleep (insomnia), disturbed sleep (apnea), and excessive sleep (narcolepsy). Insomnia, which is considered the most common disorder, is believed to affect over 60 million Americans.   Read More

Article Of The Month

  • Impact of GST Rate on Life-Saving Drugs and Other Pharma
The Indian pharmaceutical industry is the principal supplier of generic drugs all over the world, with 80% of all AIDS drugs produced in India. The UN has provided licenses to six Indian pharmaceutical labs to make generic anti-AIDS medicine for all the developing nations. Indian pharmaceutical companies manufacture 20% of all generic drugs used around the world.  Read More
  
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