FDA

  • 483 Roundup: FDA Cites Firms Over Complaint Handling, Other Deficiencies
The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Following an April inspection of the firm's Beaverton, Ore., facility, the FDA issued a Form 483 with 14 observations.  Read More
  • FDA's Generic Drugs Office Passes Last Year's Record for ANDAs Received.
Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016's total of 852 and beating fiscal 2015's total by more than 330 applications.  Read More

MERGER and ACQUISITION
  • Valeant, searching for cash, nears $2B sale of its Bausch & Lomb surgery business
Valeant Pharmaceuticals, on a mission to raise cash and pay down debt, is in talks to sell its Bausch & Lomb eye surgery business to Germany-based Carl Zeiss Meditec, Finanzen reported, citing Bloomberg.  Read More
  • Stada's 5.32B euro buyout bombs, failing to get enough shareholder support
German generics maker Stada is back on the market. Just weeks after announcing a 5.32 billion euro ($5.63 billion) buyout by private equity investors, the deal has failed, unable to get enough support from shareholders. Stada in May agreed to be acquired by London-based private equity firm Cinven and Boston investment firm Bain Capital for essentially 66 euro a share, a 48.9% premium.   Read More

FINANCIAL
  • For the first time, analyst group lowers 2022 sales forecast as pricing backlash takes a toll
For a decade, each new projection for drug sales from analyst group Evaluate has been higher than the last as new blockbusters and price hikes have pushed up its forecasts. Not this year.   Read More
  • Shire's $800M Lialda confronted by generic competition but Zydus copy will fly solo for now
After years of patent battles, the last legal barrier between Shire and a generic version of its lucrative ulcerative colitis drug Lialda has fallen and the FDA has approved a generic from ZydusCadila.It is a rude surprise for Shire investors who had believed the $800 million drug was safe for a few more years, but there is a chance that instead of flood of generics, the Zydus copy may be the only competition for a while.   Read More

CLINICAL RESEARCH
  • Survey: Global clinical operations need to unify clinical applications
There is an industry-wide drive toward a unified clinical operating model, according to the Veeva 2017 Unified Clinical Operations Survey, one of the industry's largest annual surveys of clinical operations professionals. The new research from Veeva Systems reveals that nearly all respondents cite the need to unify their clinical applications, including EDC, CTMS and eTMF.   Read More
  • Publication bias and clinical trial outcomes reporting
Last month, the world's leading funders of medical research and international non-governmental organizations agreed to set forth new standards that will require all clinical trials they fund or support to be registered, and the results disclosed publicly within mandatory timeframes.  Read More

INDIAN PHARMA
  • GST to be tax neutral for pharma
Different products will attract different rates but will benefit the end users. There is no need to panic. The difference in prices will be manageable. GST will be tax neutral for pharma segment.  Read More
  • Indian firms' drug approvals by US rise 50% in 2017.
At a time when the US business for the Indian pharmaceutical industry is in slow lane, drug approvals by the US Food and Drug Administration (FDA) have risen sharply. Data collated from the FDA website show between January and June, Indian companies, including their US-based subsidiaries, received 141 drug approvals.   Read More

VEEDA NEWS

  • Fourth Time in a row: Times Network has recognized Veeda as the "Best Clinical Research" organization for the excellence in healthcare.
7th July 10, 2017, Mumbai. It gives us immense pleasure to share an exhilarating. Followed by the trail of awards in last couple of months, we have once again done it at a national level and grabbed the award in the field of excellence in clinical research. We are delighted to let you know that Times Network has recognized Veeda as the "Best Clinical Research" organization for the excellence in healthcare. Our MD Mr. Apurva Shah in below picture receiving the honors by Times Network.   Read More
  • VEEDA CLINICAL RESEARCH awarded as Best Pharmaceutical CRO 2017 by APAC Indian Business Excellence Awards.
Veeda Clinical Research has been awarded as "Best Pharmaceutical CRO 2017" by APAC Indian Business Excellence Awardsbased in UK. The Indian Excellence Awards 2017 have been created to recognize and reward the outstanding accomplishments made by those within their respective industries.Read More

July Disease Focus

  • Focus on Pharmacotherapy for Depression
Each year approximately 21 million Americans suffer a major depressive episode, or about 16% of the population. The lifetime prevalence of depression in women is 10-25% and 5-12% for men. First-degree relatives of patients with depression are 1.5-3 times more likely to develop depression.  Read More

Article Of The Month

  • All you wanted to know about...US FDA FORM 483
The Indian pharmaceutical industry has been through a tough time. One major pain point is regulatory clampdown, especially from the US FDA (Food and Drug Administration).  Read More
  
VEEDA CLINICAL RESEARCH PVT. LTD.

Vedant Complex, Beside YMCA club S.G.Highway, Vejalpur,Ahmedabad-380051,Gujarat India

  +91 79 3001 3000 |   +91 79 3001 3010 |   info@veedacr.com |   www.veedacr.com