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lynparza

Europe approves Lynparza in HER2-, gBRCAm advanced breast cancer

April 10, 2019
Research and Development, Sales and Marketing AstraZeneca, Cancer, MSD, breast cancer, lynparza, pharma

Lynparza (olparib), the poly ADP ribose polymerase (PARP) inhibitor developed by AstraZeneca and MSD, has been awarded marketing approval by …

News
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New Yorkers must be vaccinated or face a fine

April 10, 2019
Research and Development Brooklyn, New York, infectious diseases, measles, public health, vaccines

A public health emergency has been declared in New York following an outbreak of measles. Residents of certain postcodes in …

News
senatefloor

Pharmacy Benefit Manager (PBM) execs testify before US Senate

April 10, 2019
Research and Development PBMs, Rebates, Senate, US, pharma, senator, sfc

Executives representing pharmacy benefit managers (PBMs) appeared before the US Senate Finance Committee on Tuesday as they testified on the …

News
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Epilepsy Society calls for review of UK supply chain following “steep rise” in access issues

April 9, 2019
Manufacturing and Production, Sales and Marketing Epilepsy Society, UK, brexit, epilepsy, market access, pharma

The Epilepsy Society has drawn attention to the “steep rise” in UK patients who are encountering difficulty in accessing seizure …

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United Therapeutics terminates oral pulmonary arterial hypertension drug following Phase 3 failure

April 9, 2019
Manufacturing and Production, Research and Development Tyvaso, United Therapeutics, pharma, pulmonary arterial hypertension

United Therapeutics has revealed in a short announcement that, because its pulmonary arterial hypertension (PAH) therapy failed to meet its …

News
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FDA refuses to review Zogenix’s Fintepla in Dravet syndrome, shares tumble 30%

April 9, 2019
Manufacturing and Production, Sales and Marketing Dravet Syndrome, FDA, Fintepla, Zogenix

California-based biopharma firm Zogenix has been left frustrated after it received a correspondence from the FDA noting its refusal to …

News

ViiV Healthcares scores first twin-drug FDA approval for untreated HIV-1

April 9, 2019
Manufacturing and Production, Research and Development GSK, HIV, ViiV Healthcare, pharma

ViiV Healthcare, the pharmaceutical firm owned by Shionogi, Pfizer and predominantly GSK, has announced its two-drug HIV regimen Dovato (dolutegravir …

News

Eisai and MSD’s Lenvima recommended for NHS Scotland in advanced or unresectable liver cancer

April 8, 2019
Manufacturing and Production, Sales and Marketing Cancer, NHS, Scotland, Scottish Medicines Consortium, UK, liver cancer, pharma

Patients in Scotland with with advanced or unresectable hepatocellular carcinoma (HCC) will now be able to access Eisai and MSD’s …

News
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Kymab announces Merck exec Simon Sturge as new CEO

April 8, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Boehringer Ingelheim, appointment, kymab, pharma

UK-based biotech Kymab has identified Merck KGaA executive Simon Sturge as its new Chief Executive Officer, taking over the reins …

Appointment
real_world

Protecting public health: Is real-world evidence the key?

April 8, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing feature, pharma, real world data, real world evidence, real-world data, real-world evidence

In often tough regulatory climates and with threats to public health are growing in sceptical corners of society, the need …

Feature

NICE turns down Astellas’ Xtandi in prostate cancer

April 8, 2019
Research and Development, Sales and Marketing Astellas, Cancer, NHS, NICE, UK, pharma, prostate cancer

Astellas’ Xtandi (enzalutamide) has been rejected by UK medicines watchdog NICE for use on the NHS as a therapy for …

News
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Alnylam and Sanofi close research phase of 2014’s $700m RNAi rare disease partnership

April 8, 2019
Research and Development, Sales and Marketing Alnylam, Genzyme, Sanofi, pharma, rare disease

Alnylam and Sanofi have announced their intention to bring to an end the research and option phase of a $700 …

News
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Osteoporisis risk in over half of European women over 70, three-quarters not treated, Amgen study finds

April 8, 2019
Research and Development, Sales and Marketing Amgen, Europe, UK, bones, osteoporosis, pharma, real world data, real-world data

A new study from Amgen analysing real-world data has revealed that more than half of European women over 70 years …

News
johnson_and_johnson_jj

€100m expansion of J&J’s Limerick manufacturing facility to bring up to 300 jobs

April 8, 2019
Manufacturing and Production, Sales and Marketing

Johnson & Johnson has revealed plans to expand its existing Vision Care facilities at the National Technology Park in Limerick, …

News
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Merrimack shuts down development of investigational cancer drug, staff cuts to follow

April 8, 2019
Research and Development, Sales and Marketing cacner, merrimack, oncology, pharma

Merrimack Pharmaceuticals has taken the decision to terminate development of its antibody-directed nanotherapeutic cancer therapy MM-310 in the treatment of …

News
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Top Ten most popular articles on Pharmafile.com this week!

April 5, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, AstraZeneca, Northern Ireland, Novartis, Placebo, UK, brexit, pharma

As Brexit looms, pharma trade lobby the ABPI called for a ban on exports of medicines in the case of …

News

FDA approves Pfizer’s Ibrance for advanced male breast cancer

April 5, 2019
Medical Communications, Sales and Marketing Cancer, FDA, Pfizer, breast cancer, ibrance, male breast cancer, pharma

The FDA has chosen to expand the indications of Pfizer’s Ibrance (palbociclib), the company announced, approving the CDK4/6 inhibitor in …

News

BMS Opdivo/Yervoy recommended for untreated kidney cancer via Cancer Drugs Fund

April 5, 2019
Medical Communications, Sales and Marketing CDF, Cancer, Cancer Drugs Fund, Kidney cancer, NICE, UK, Yervoy, opdivo

NICE has revealed it is recommending that Bristol-Myers Squibb’s Opdivo (nivolumab), in combination with Yervoy (ipilimumab), be made available to …

News
920x920

Sacklers file motion to throw lawsuit out of court

April 5, 2019
Medical Communications Massachusetts, OxyContin, Purdue Pharma, opioid crisis, opioids, sackler

Members of the Sackler family have asked a judge to throw a lawsuit – filed by Massachusetts attorney general Maura …

News

Memorial Sloan Kettering Cancer Center officials violated conflict of interest policies

April 5, 2019
Medical Communications, Research and Development Cancer, Memorial Sloan Kettering Cancer Center, oncology, research

Top officials at the Memorial Sloan Kettering Cancer Center repeatedly violated policies on financial conflicts of interest, according to details …

News
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