FDA issues draft guidance on topical drug ingredients

The agency is taking a closer look at how API are absorbed through the skin now that better technologies allow for more accurate monitoring. 

By Suzanne Elvidge • May 24, 2018

AstraZeneca raising profile in Bay Area

A new facility in South San Francisco will serve to consolidate the pharma's Bay area operations.

By Lisa LaMotta • May 23, 2018

Bioasis signs manufacturing deal with WuXi Biologics

Partnering with the Chinese CDMO should help Bioasis move one of its preclinical drug programs into the clinic.

By Suzanne Elvidge • May 23, 2018

Right to Try bill clears House, headed for Trump signature

FDA chief Scott Gottlieb had expressed reservations about the impact on agency authority.

By David Lim • May 22, 2018

11 technologies set to shape smart manufacturing

New tools like 3D printing and AI have already led to technological shifts, revealing a new wave of supply chain efficiencies yet to be unlocked.

By Jordan Branch , Edwin Lopez • May 21, 2018

Senate Dem says raising drug prices abroad won't help US

The generic drug lobby has concerns that tariffs proposed by the Trump administration, including on pharmaceutical ingredients and products from China, would lead to increased manufacturing costs and higher drug prices.

By David Lim • May 21, 2018

GE boosts cell culture media production tenfold

The manufacturing giant hopes the expansion in Austria and the U.S. will meet growing demand from industry. 

By Suzanne Elvidge • May 18, 2018

Cambrex expands high potency API capabilities

Work on a pilot plant in North Carolina has wrapped, while construction is underway of a new facility in Iowa. 

By Suzanne Elvidge • May 17, 2018

FDA issues warning letter to India's Goran Pharma

The agency suggests the company get help to sort out its facility issues.

By Suzanne Elvidge • May 16, 2018

Gilead finds new home in Europe for CAR-T manufacturing

By leasing a facility near the Amsterdam airport, Gilead will be better positioned to support commercialization in Europe of its cancer cell therapy, Yescarta.

By Ned Pagliarulo • May 15, 2018

Macrogenics taps AGC Biologics for commercial manufacturing

The CDMO will prepare to commercially supply Macrogenics' cancer drug margetuximab, which is making its way through Phase 3 study. 

By Suzanne Elvidge • May 14, 2018

What to expect from Trump's Friday drug pricing speech

The president is expected to lay out his administration's latest slate of proposals aimed at lowering the cost of drugs.

By David Lim • May 10, 2018

Avid CEO talks expansion, capacity and Asia

In an interview with BioPharma Dive, Avid's Roger Lias decribes the opportunities now open to the full-service biologics CDMO.

By Randi Hernandez • May 10, 2018

Proteon and Lonza extend manufacturing agreement

With Proteon's experimental drug moving through Phase 3, the biotech sought to secure long-term supply of the drug's active pharmaceutical ingredient. 

By Suzanne Elvidge • May 10, 2018

Ritter taps Medpace as CRO for Phase 3 microbiome study

Bringing on board a CRO moves Ritter a step closer to beginning pivotal trials for its microbiome booster.

By Suzanne Elvidge • May 9, 2018

EpiPen shortage tied to Pfizer manufacturing issues

The FDA added the epinephrine auto-injector to its list of drugs currently in shortage due to production issues.

By Lisa LaMotta • May 9, 2018

Lonza expands key New Hampshire biologics plant

The Swiss manufacturer will also add cell therapy suites to the site, further bolstering its push into the fast-growing field. 

By Suzanne Elvidge • May 7, 2018

Fremanezumab approval by mid-June unlikely, Teva says

Issues at Teva's contract manufacturer appear to have tripped up the migraine drug's application, although the generics giant still expects an OK by year-end.

By Ned Pagliarulo • May 3, 2018

WuXi steps outside China with Ireland plant plans

The biologics manufacturer will invest $390 million into building a huge single-use bioreactor plant in pharma's favorite home for drug production. 

By Suzanne Elvidge • May 1, 2018

3 FDA warning letters issued for GMP hitches

Inspectors from the U.S. regulator flagged violations at production plants in China, Mexico and Florida. 

By Randi Hernandez • April 30, 2018

Zoetis doubles down on animal vaccines

The animal health spinout will beef up its manufacturing footprint in China with two new facilities that will focus on vaccines, particularly for farmed fish. 

By Randi Hernandez • April 27, 2018

Shionogi dives into Japan's growing CMO sector

Seeing local demand for contract manufacturing, the Japanese pharma plans to set up a new unit to produce drugs developed by others as well as its own.

By Randi Hernandez • April 26, 2018

Shire, tight-lipped on Takeda, focuses on portfolio's potential

Investors craved details on a potential takeover, but Shire instead harped on Xiidra pickup, Cinryze stock and the resiliency of its hemophilia business.

By Jacob Bell • April 26, 2018

Noven resolves FDA warning for Miami facility

After receiving a close-out notice from the FDA, the company can now move past a 2016 warning letter. 

By Suzanne Elvidge • April 26, 2018

Avid Bioservices expands facility, process development capabilities

New capital investments supporting facility growth are part of Avid's transformation into a dedicated CDMO.

By Randi Hernandez • April 25, 2018