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New Year, new goals

February 8, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CRUK, Cancer Research UK, Chiesi, EMA, FDA, Genetic Alliance, pharma

With the New Year begun in earnest, Pharmafocus speaks to a range of players in pharma and the life sciences …

Feature
facilities_lg06

Dr Reddy’s hit by yet another recall, of 80,000+ bottles

February 8, 2018
Sales and Marketing Dr Reddy's, FDA, biotech, drugs, pharma, pharmaceutical

Dr Reddy’s Laboratories problem with ensuring products reach the market at a quality the FDA deems acceptable is no secret …

News
gilead-sciences

FDA approves Gilead’s Biktarvy for HIV as Viiv Healthcare launches patent lawsuit

February 8, 2018
Sales and Marketing Biktarvy, FDA, GSK, Gilead, HIV, Pfizer, Shionogi, US, ViiV Healthcare, descovy, pharma

Gilead has announced that its daily single-tablet therapy Biktarvy has received FDA approval for HIV-1 infection.

News
novartis_window

Novartis tastes own medicine, Advair generic delayed

February 8, 2018
Sales and Marketing FDA, Novartis, biotech, drugs, pharma, pharmaceutical

Novartis had not been frontrunner to receive approval for its generic version of GSK’s Advair – lagging behind Mylan’s generic …

News
allergan

Allergan’s Avycaz becomes first FDA-approved gram-negative antibiotic in over 15 years

February 2, 2018
Medical Communications, Sales and Marketing Allergan, Avycaz, FDA, pharma, pneumonia

Allergan has announced that the FDA has awarded approval to its fixed-dose combination antibacterial Avycaaz (ceftazidme and avibactam) for the …

News
bellicum_pharma_give_credit

FDA halts Bellicum trial over brain disease in participants, shares crash 48%

February 1, 2018
Research and Development Bellicum Pharmaceuticals, FDA, encephalopathy, pharma, trial failure

Texas-based clinical-stage company Bellicum Pharmaceuticals has taken a massive stock hit after the FDA put a hold on its trials …

News
squirrel-monkey-1335598_960_720

FDA revises methods, after public outrage at testing of monkeys

January 29, 2018
Manufacturing and Production, Medical Communications FDA, biotech, drugs, pharma, pharmaceutical

The story broke in September of last year that the FDA was testing nicotine addiction in squirrel monkeys and that …

News

iQOS heat-not-burn electronic tobacco product doesn’t reduce health risk, FDA says

January 26, 2018
Medical Communications, Sales and Marketing FDA, Philip Morris, iQOS, pharma, smoking, tobacco

An advisory panel of the FDA has judged that US tobacco firm Philip Morris International (PMI) has not been able …

News
novartis_outside_1

Novartis’ CAR T therapy Kymriah scores accelerated approval in both Europe and US

January 17, 2018
Research and Development, Sales and Marketing CAR T, CAR-T, EMA, Europe, FDA, Kymriah, Novartis, US, pharma

Following up last year’s ground-breaking news that CAR T therapy Kymriah had become the first such treatment to be approved …

News

Boehringer’s Gilotrif approved in US for lung cancer with non-resistant EGFRs

January 16, 2018
Manufacturing and Production, Sales and Marketing Boehringer Ingelheim, Cancer, FDA, Giltrif, NSCLC, lung cancer

Boehringer Ingelheim is celebrating the FDA’s decision to expand the indication of its lung cancer drug Gilotrif (afatinib) to include …

News
teva_canada_1

FDA expands indication of Teva’s Trisenox for acute promyelocytic leukaemia

January 16, 2018
Manufacturing and Production, Sales and Marketing FDA, Teva, acute promyelocytic leukaemia, leukaemia, pharma

Teva has announced that its Trisenox (arsenic trioxide) injection has been awarded US approval from the FDA in combination with …

News
fda2outsideweb

AZ and MSD’s Lynparza becomes first PARP inhibitor approved in US for metastatic breast cancer

January 15, 2018
Sales and Marketing AstraZeneca, Cancer, FDA, MSD, breast cancer, lynparza, pharma

The FDA has announced that it has awarded marketing authorisation in the US to Lynparza (olaparib), a poly ADP-ribose polymerase …

News
kid_ill

FDA steps in to prohibit codeine cough syrups for children

January 12, 2018
Medical Communications FDA, biotech, drugs, pharma, pharmaceutical

The FDA has announced that it will require all labels to state that cough syrups containing codeine or hydrocodone are …

News
dermapace-product

FDA approves shock wave wound healing device

January 2, 2018
Manufacturing and Production, Sales and Marketing FDA, biotech, drugs, pharma, pharmaceutical

Continuing its recent trend to promote innovative new technologies, the FDA has announced that it has approved a medical device …

News
fda2outsideweb

La Jolla Pharmaceutical scores FDA approval for blood pressure treatment

December 22, 2017
Medical Communications, Sales and Marketing FDA, La Jolla pharmaceutical, blood pressure, pharma

The FDA has announced that it has approved La Jolla Pharmaceutical’s Giapreza (angiotensin II) injection for intravenous infusion to increase …

News
The Gateway to Local Adoption Series

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