Compressed air quality
Particle analysis methods and ISO 8573 Standard updates (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 13, 2019 Category: Pharmaceuticals Source Type: news

Pharma in review: trending stories 12/13/19
Most popular Pharma Manufacturing stories from the past seven days. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 13, 2019 Category: Pharmaceuticals Source Type: news

Lilly, Boehringer's Jardiance has heart failure trial setback
Boehringer Ingelheim and Eli Lilly announced failing results in two trials evaluating Jardiance in adults with chronic heart failure. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 13, 2019 Category: Pharmaceuticals Source Type: news

FDA oks Sarepta muscular dystrophy drug after previous rejection
The U.S. FDA granted an accelerated approval to Sarepta Therapeutics'therapy for Duchenne muscular dystrophy, reversing its original rejection. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 13, 2019 Category: Pharmaceuticals Source Type: news

Digital transformation delayed
Should technology vendors shoulder some of the blame for pharma ’s digital stagnation? (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 12, 2019 Category: Pharmaceuticals Source Type: news

Trump nixes biologic protections in new trade deal
A new trade pact being negotiated between the U.S., Mexico and Canada has been stripped of provisions that would have protected drugmakers from biosimilar competition for at least a decade. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 11, 2019 Category: Pharmaceuticals Source Type: news

Correvio might look for buyer after FDA panel shoots down heart drug
Correvio Pharma Corp could hunt for a potential buyer now that its pivotal heart drug is not likely to win FDA approval. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 11, 2019 Category: Pharmaceuticals Source Type: news

J & amp;J CEO declines appearance at U.S. congressional hearing on talc carcinogens
According to the House of Representatives Subcommittee on Economic and Consumer Policy, Johnson& Johnson CEO Alex Gorsky declined to testify even after over a month of attempts to accommodate the company. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 10, 2019 Category: Pharmaceuticals Source Type: news

Sanofi, Regeneron restructure 12-year-old partnership
The existing collaboration relating to Dupixent (dupilumab), which recently reached $633 million in global sales, will remain unchanged following the restructuring (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 10, 2019 Category: Pharmaceuticals Source Type: news

Why labeling matters
How modern, centralized label management systems can give pharma companies an edge (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 10, 2019 Category: Pharmaceuticals Source Type: news

Execs face jail time for Samsung Biologics fraud
A court in South Korea has handed out prison sentences for three Samsung executives involved in accounting fraud at the company ’s biotech arm. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 9, 2019 Category: Pharmaceuticals Source Type: news

Merck makes big cancer buy with $2.7B ArQule deal
Another day — another big oncology deal in pharma. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 9, 2019 Category: Pharmaceuticals Source Type: news

Product Focus: Keepin' it clean
Innovations that make life easier in the cleanroom (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 9, 2019 Category: Pharmaceuticals Source Type: news

FDA removes hold on pivotal gene therapy trial
Abeona Therapeutics announced that the U.S. FDA has removed its clinical hold on the company ’s pivotal Phase 3 clinical trial evaluating gene therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 9, 2019 Category: Pharmaceuticals Source Type: news

Sanofi to acquire Synthorx for $2.5B
Sanofi will acquire clinical-stage biotechnology company, Synthorx, for approximately $2.5 billion. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 9, 2019 Category: Pharmaceuticals Source Type: news

Pharma in review: trending stories 12/6/19
Most popular Pharma Manufacturing stories from the past seven days. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 6, 2019 Category: Pharmaceuticals Source Type: news

FDA approves first generics of Novartis blockbuster MS drug
The U.S. FDA has approved three applications for first generics of Gilenya capsules for the treatment of relapsing forms of multiple sclerosis in adults. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 6, 2019 Category: Pharmaceuticals Source Type: news

The next decade of cleanrooms
Pre-fab and modular cleanrooms are on the rise, but stick-built still dominate. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 6, 2019 Category: Pharmaceuticals Source Type: news

Novartis partners with Amazon to boost manufacturing efficiency
Novartis will work with Amazon ’s cloud-computing unit, Amazon Web Services, to make the manufacturing and delivery of new medicines more efficient. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 6, 2019 Category: Pharmaceuticals Source Type: news

Moving beyond the last frontier of paper
Hear the current regulatory perspective on digitalization and what that means for pharma from a former FDA auditor (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 6, 2019 Category: Pharmaceuticals Source Type: news

Pharma's struggle to find balance
Other manufacturing sectors, such as automotive, food and electronics, have long used automated technology in their factories. However, it has been difficult for the pharmaceutical industry to implement automation and other industrial technologies on quite the same scale. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 5, 2019 Category: Pharmaceuticals Source Type: news

EMA asks pharma to test diabetes drugs for NDMA
Common diabetes drugs have become the newest target of an ongoing NDMA scare in pharma. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 5, 2019 Category: Pharmaceuticals Source Type: news

Merck spars with insurers over $1.3B cyberattack
Merck says that the attack wiped out years of research data, hampered work at facilities and cost the company $1.3 billion in damages. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 5, 2019 Category: Pharmaceuticals Source Type: news

The future of cold chain logistics
Coming to a supply chain near you (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 3, 2019 Category: Pharmaceuticals Source Type: news

Biocon and Mylan nab FDA approval for Herceptin biosim
Co-developed by both companies, Ogivri will be used for the treatment of breast and gastric cancer patients. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 3, 2019 Category: Pharmaceuticals Source Type: news

AstraZeneca sells more Seroquel rights to Cheplapharm for $42 million
Cheplapharm now adds the rights in United States and Canada to its recently acquired ones for Seroquel and Seroquel XR in most European markets and Russia. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 3, 2019 Category: Pharmaceuticals Source Type: news

FDA denies Lexicon appeal of drug rejection
Lexicon Pharmaceuticals has failed in its efforts to appeal a rejection from the FDA for its diabetes drug, Zynquista. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 3, 2019 Category: Pharmaceuticals Source Type: news

Astellas to shell out $3 billion in gene therapy takeover
Japan-based Astellas Pharma is dropping nearly $3 billion in cash to scoop up San Francisco ’s Audentes Therapeutics. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 3, 2019 Category: Pharmaceuticals Source Type: news

The crux of an effective pharma recall
Pharma can take steps now to prepare for the interconnected, digital supply chain (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 2, 2019 Category: Pharmaceuticals Source Type: news

Samoan government shuts down over measles outbreak
The Samoan government will shut down for two days as part of a series of drastic steps being taken to stop a deadly outbreak of measles. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 2, 2019 Category: Pharmaceuticals Source Type: news

Lilly opens shared innovation lab
Eli Lilly and Company unveiled its first shared innovation lab, located in South San Francisco, designed to speed the discovery of innovative medicines through collaboration. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 2, 2019 Category: Pharmaceuticals Source Type: news

Secure data transfer in the supply chain
How blockchain technology can help create secure document trails and facilitate efficient audits (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 29, 2019 Category: Pharmaceuticals Source Type: news

Harvard, MIT, hospitals and industry create facility for next-generation med development
They will pool resources to create a new $50 million center for advanced biological innovation and manufacturing in Boston. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 26, 2019 Category: Pharmaceuticals Source Type: news

Global Blood Therapeutics wins first FDA approval with sickle cell disease med
The drugmaker says its drug, Oxbryta, can be used in combination with Novartis ’s drug, Adakveo, which nabbed FDA approval just last week (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 26, 2019 Category: Pharmaceuticals Source Type: news

6 pharma supply chain innovations that are worth the investment
To increase profitability, the health care industry must leverage advanced technology to create efficient processes and reduce costs. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 25, 2019 Category: Pharmaceuticals Source Type: news

CymaBay halts liver drug studies
CymaBay Therapeutics announced that it is stopping several liver disease studies after liver damage was detected in some patients. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 25, 2019 Category: Pharmaceuticals Source Type: news

Roche ’s new flu drug could trigger drug-resistant strain of influenza
New research has shown that Roche ’s one-and-done influenza pill could cause mutations of the influenza virus that are resistant to the treatment. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 25, 2019 Category: Pharmaceuticals Source Type: news

Novartis to buy cholesterol-drug maker for $9.7B
Novartis has reached a deal to buy cholesterol-drug maker The Medicines Co. for $9.7 billion. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 25, 2019 Category: Pharmaceuticals Source Type: news

Sanofi considers sale, spin-off, joint venture of consumer healthcare unit
Sanofi is considering a joint venture, spin-off or outright sale of its consumer healthcare unit, according to Reuters sources. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 25, 2019 Category: Pharmaceuticals Source Type: news

Transforming data management
Cloud-based LIMS provide pharmaceutical manufacturers with a scalable and flexible solution (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 22, 2019 Category: Pharmaceuticals Source Type: news

Pharma in review: trending stories 11/22/19
Most popular Pharma Manufacturing stories from the past seven days. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 22, 2019 Category: Pharmaceuticals Source Type: news

Roche extends Spark deadline again...and again
Roche has extended the deadline for its tender offer for Spark Therapeutics saying U.S. and British anti-trust authorities needed additional time to review the deal. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 22, 2019 Category: Pharmaceuticals Source Type: news

AstraZeneca gets FDA ok for lymphocytic leukemia drug
AstraZeneca announced that the U.S. FDA has approved Calquence for adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 21, 2019 Category: Pharmaceuticals Source Type: news

To biopharma: Which elephant?
Biopharma is taking small steps towards solving one of many jumbo challenges (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 21, 2019 Category: Pharmaceuticals Source Type: news

FDA warns Torrent for water system laced with bacteria
The FDA has slapped India-based Torrent Pharmaceuticals with a warning letter for its water system at a Pennsylvania facility. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 20, 2019 Category: Pharmaceuticals Source Type: news

Lilly plans $400M manufacturing investment
Eli Lilly and Co. has announced a manufacturing expansion in Indianapolis that will add 100 new high-skilled jobs to its operations. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 20, 2019 Category: Pharmaceuticals Source Type: news

How tech plays a critical role in meeting upcoming DSCSA deadlines
With less than a month to go until these new regulations take effect, even the most prepared companies will encounter stark realities. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 20, 2019 Category: Pharmaceuticals Source Type: news

Pfizer nabs FDA approval for Humira biosim
Abrilada is the fifth Humira biosimilar approved in the U.S. and will join generics from Mylan, Samsung Bioepis and Sandoz when AbbVie's blockbuster has its patent expire in 2023. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 19, 2019 Category: Pharmaceuticals Source Type: news

Roche buys biotech Promedior in $1.39 billion deal
The Swiss drugmaker will pay $390 million upfront for the privately held biotechnology company specializing in the development of targeted medicines to treat fibrosis. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 19, 2019 Category: Pharmaceuticals Source Type: news

Amgen announces plan to axe 172 jobs
Facing stiffening biosimilar and generics competition, Amgen said it has to cut 172 jobs later this year. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 19, 2019 Category: Pharmaceuticals Source Type: news