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INTERPHEX 2019: Still hip at forty

(Article)

INTERPHEX 2019 conference recap

Insys agrees to $225M opioid settlement

(News)

Insys Therapeutics has agreed to pay $225 million to settle the federal government's criminal and civil investigations into the company's marketing practices for it's fentanyl-based medication, Subsys.

Trump halts fetal-tissue research

(News)

The Trump administration announced that the federal government would sharply limit federal spending on medical research that uses tissue from aborted fetuses.

Lilly scores big win with expanded approval for migraine treatment

(News)

For the first time ever, the FDA has approved a medication to treat cluster headaches.

Report: Pfizer passed on promising Alzheimer’s research

(News)

A few years ago, researchers inside Pfizer reportedly discovered that one of the company’s blockbuster drugs could be a breakthrough treatment for Alzheimer’s.

Bayer partners with Arvinas in $750M biotech deal

(News)

The German drugmaker will be providing an upfront payment, pharmaceutical R&D support and an investment $60 million.

FDA expands Merck antibiotic indication to pneumonia treatment

(News)

The previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.

How to boost your chances of winning an FDA drug approval

(Article)

The commercialization of a new drug follows a rigid path and applying for FDA approval can be a minefield of challenges. Here are expert tips for nailing your application.

Instrumental in profitability

(Article)

Automation: Reaping the benefits from improved instrument verification and calibration procedures.

Experimental Amgen drug gets positive results in cancer trial

(News)

A treatment that targets a specific genetic mutation has proven to be effective in shrinking tumors in some patients with advanced lung cancer.

FDA hearing on CBD raises more questions than answers

(News)

On Friday, the FDA listened to testimonies from over 100 stakeholders in the growing market for CBD, a non-psychoactive compound found in marijuana.

Gilead rolls out new CAR-T data at ASCO

(News)

Gilead's Kite announced findings from new analyses of CAR-T treatments at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Investigation says pharma games orphan drug rules

(News)

A Kaiser Health News investigation claims that the Orphan Drug Act is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions.

Revalidating grandpa

(Article)

For pharma, it pays to update facilities and mindsets

Pfizer shifts focus to rural china

(News)

Pfizer is shifting its attention to remoter regions of China in an effort to offset the impact of government price-cutting policies on sales of its aging blockbusters.

Novartis-backed cancer biotech raises $30M

(News)

Ayala Pharmaceuticals has raised $30 million in a series B funding round, led by Novartis.

OEE betters the batch

(Article)

New technology allows equipment data to be aggregated and analyzed, facilitating best practices across all batches.

New gene therapy may not be ‘one-and-done’ home run

(News)

BioMarin Pharmaceutical reported this week that the effects of its new gene therapy may diminish over time.

Study questions efficacy of cancer drugs in FDA’s accelerated approvals program

(News)

A new study has revived the debate over whether or not cancer drugs fast-tracked through the FDA’s accelerated approvals program actually help patients.

eBook: Solid Dose Trends 2019

(Whitepaper)

Q&A: Tablet production

(Article)

Pharma Manufacturing sat down with tableting expert, Alex Bunting, I Holland, to discuss common tablet manufacturing problems and fixes.

FDA expands Allergan's Vraylar for bipolar depression treatment

(News)

Vraylar is also approved for schizophrenia in adults and for manic or mixed episodes associated with bipolar I disorder.

Novartis breast cancer med nabs FDA approval

(News)

The drug, Piqray, is the first new drug application approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program.

Researchers closer to developing vaccine for strep throat

(News)

A group of scientists say they are getting closer to developing a vaccine that could help prevent strep throat and scarlet fever.

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