Latest News in the pharma Industry

Policy & Regulation

FDA Issues Draft Guidance to Industry on Tablet Scoring

FDA Issues Draft Guidance to Industry on Tablet Scoring

6 Sep 2011

The FDA has issued a draft of guidance to the pharmaceutical industry on Tablet Scoring: Nomenclature, Labelling, and Data for Evaluation.

Read more 
FDA Grants Fast-track Designation to Aicuris Human Cytomegalovirus Drug

FDA Grants Fast-track Designation to Aicuris Human Cytomegalovirus Drug

5 Sep 2011

The US FDA has granted fast track status to AiCuris' HCMV drug Letermovir.

Read more 
FDA Urged to Revise Regulations on Generic Drug Labelling

FDA Urged to Revise Regulations on Generic Drug Labelling

2 Sep 2011

FDA currently prevents generic drug makers to update labels even if they are made aware of an unstated risk to the consumer, as they must remain identical to the original brand-name product.

Read more 
Roche’s Tarceva Receives European Approval

Roche’s Tarceva Receives European Approval

2 Sep 2011

This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations.

Read more 
FDA Requests More Data of Novartis Gout Drug

FDA Requests More Data of Novartis Gout Drug

31 Aug 2011

The FDA requested additional information surrounding canakinumab including clinical data to evaluate the benefit-risk profile in refractory patients.

Read more 
FDA Approves Pfizer's Lung Cancer Therapy

FDA Approves Pfizer's Lung Cancer Therapy

30 Aug 2011

Pfizer announced that it received US approval for its lung cancer drug Xalkori.

Read more 
FDA Gives Market Nod to J&J Pain Drug

FDA Gives Market Nod to J&J Pain Drug

29 Aug 2011

The approval follows J&J's study showing the safety and efficacy of the drug in Phase III studies.

Read more 
FDA Gives Fast-track Status to Algeta's Prostate Cancer Treatment

FDA Gives Fast-track Status to Algeta's Prostate Cancer Treatment

29 Aug 2011

Algeta's radium-223 chloride has been granted fast-track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.

Read more 
Linagliptin Receives Approval in Europe to Treat Type 2 Diabetes

Linagliptin Receives Approval in Europe to Treat Type 2 Diabetes

29 Aug 2011

The approval of linagliptin in Europe was based on a clinical trial program which involved approximately 6,000 adults with type 2 diabetes.

Read more 
Hepatitis C Drug PSI-938 Granted FDA Fast-track Designation

Hepatitis C Drug PSI-938 Granted FDA Fast-track Designation

29 Aug 2011

Fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition.

Read more 
Health Canada OKs Hepatitis Drug Incivek

Health Canada OKs Hepatitis Drug Incivek

26 Aug 2011

Vertex Pharmaceuticals receives Health Canada approval for Incivek tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease.

Read more 
EMA: New Validation Criteria for Electronic Submissions into Effect Next Month

EMA: New Validation Criteria for Electronic Submissions into Effect Next Month

25 Aug 2011

According to EMA's note, new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.

Read more