How to go fast to IND: 3 tips to combine speed with quality

A survey of small-biopharma leaders on their plans and concerns for developing their molecules shows three issues of highest importance: getting their drugs to the clinic quickly, finding expert help and having adequate funding.

May 17, 2019

B. Braun invests $1B in IV fluid manufacturing to alleviate shortages

Weather events like Hurricane Maria have fueled an IV solution shortage B. Braun hopes to address by opening, updating and expanding production sites.

By David Lim • May 16, 2019

FDA highlights manufacturing quality efforts after recalls, regulatory criticism

An agency report found the industry's average inspection score didn't change much over the last two years, though there remain concerns about quality control in China and India.

By Kristin Jensen • May 16, 2019

Thermo Fisher to buy GSK drug plant in Ireland

GSK will receive about $100 million from Thermo for the site, which makes API for drugs that treat conditions like depression and Parkinson's disease.

By Kristin Jensen • May 16, 2019

Chemical suppliers take hits from both sides of the trade war

Chemicals produced in the U.S. suffer from higher cost of materials imported from China and the shrinking Chinese export market due to retaliatory tariffs.

By Emma Cosgrove • May 16, 2019

Bayer pumping $150M more into biologics

A new facility will focus on large-molecule therapies for oncology, cardiology and additional specialty care areas.​

By Jacob Bell • May 13, 2019

Catalent, hindered by Softgel weakness, sees stronger growth ahead

Revenues from January to March fell 2% year over year, as the CDMO works through an ibuprofen supply shortage and an accounting change.

By Ned Pagliarulo • May 9, 2019

Charles River sees minimal financial impact from cybersecurity breach

An incident disclosed last week likely won't result in significant costs, the company told investors.

By Kristin Jensen • May 9, 2019

Renewable energy to power all Novo drug production by next year

The Danish drugmaker set out in 2015 with an ambitious goal to use only electricity generated from renewable sources in its production plants.

By Ned Pagliarulo • May 2, 2019

FDA rejects Heron, Nabriva drug applications, citing manufacturing concerns

Both biotechs expected approval of their respective pain and anti-infective drugs, but wound up with disappointment and delays.

By Andrew Dunn • May 2, 2019

Amid outbreaks, Merck ramps up measles vaccine manufacturing

The move should maintain availability and provide a greater stateside supply of the company's measles, mumps and rubella vaccine.

By Jacob Bell • May 2, 2019

Merck plans to shed facilities, cut jobs in restructuring

A planned restructuring of Merck's manufacturing and supply network will likely cost between $800 million to $1.2 billion in total, the company said.

By Kristin Jensen • May 1, 2019

Gilead to build manufacturing site in Maryland to boost cell therapy

The Kite Pharma unit is expanding a production network that includes facilities in California and the Netherlands.

By Kristin Jensen • April 25, 2019

GSK to invest $100M in Montana vaccine manufacturing site

The pharmaceutical giant looks to expand capacity for adjuvant systems, including for its high-demand shingles vaccines.

By Kristin Jensen • April 24, 2019

Lilly selling antibiotic rights, manufacturing plant in China

As with other big pharmas, antibiotics have become less of a priority for Lilly despite global concerns over the need for new treatments.

By Jacob Bell • April 23, 2019

Hospital-led generic drugmaker Civica Rx opens HQ in Utah

Civica is trying to fill a need created by what its leaders see as failures in the market for supplying lower-cost copycat drugs.

By Les Masterson • April 22, 2019

'Bubble boy' gene therapy results shoot Mustang Bio's stock up 200%

Following the clinical success, BioPharma Dive spoke with Mustang's CEO on the manufacturing hurdles still standing in the therapy's way.

By Andrew Dunn • April 18, 2019

Lonza reports pharma strength as rest of business falters

The Swiss manufacturer kept its 2019 guidance in place as growth in its pharma and biotech business made up for headwinds elsewhere.

By Kristin Jensen • April 18, 2019

Catalent to buy Paragon for $1.2B as gene therapy demand grows

The deal follows close on the heels of Thermo Fisher's buy of Brammer Bio, a peer of Paragon in making the viral vectors needed for gene therapy. 

By Jacob Bell • April 15, 2019

GSK, AstraZeneca explore continuous manufacturing in partnership with CPI

The companies are establishing a continuous wet granulation plant for small-scale development of oral solid dosage pharmaceuticals.

By Suzanne Elvidge • April 11, 2019

FDA clears 40 impurity-free ARBs to ease antihypertensive shortages

Agency officials stressed the risk to patients is small and urged those on the heart meds to consult a doctor before discontinuing them.

By Suzanne Elvidge • April 11, 2019

Lonza's CEO on keeping up with microbiome, gene therapy boom

Marc Funk told BioPharma Dive manufacturing has been an obstacle for microbiome drugmakers, something the Swiss CDMO hopes to solve with a new joint venture. 

By Ned Pagliarulo • April 11, 2019

Novo ramping up hemophilia drug production with $100M investment in Danish site

Currently producing diabetes drugs, the upgraded facilities will also make the active ingredients for NovoSeven and future hemophilia products.

By Suzanne Elvidge • April 3, 2019

Lonza launches joint venture to supply microbiome field

Together with the Danish company Chr. Hansen, Lonza is betting biotech and pharma companies developing bacteria-based therapies will need a partner.

By Kristin Jensen • April 3, 2019

AveXis buys its 4th US plant in preparation of Zolgensma launch

The six-building campus in Longmont, Colorado, gives the Swiss biotech nearly 700,000 square feet of additional space for biologic drug manufacturing.

By Jacob Bell • April 2, 2019