APIs (active pharmaceutical ingredients)

Explosion at Chinese pharmaceutical plant leaves 10 dead

22-Apr-2019 By Ben Hargreaves

Dozens hurt and 10 people dead after an accident during renovation work in Shandong province, China.

Vetter’s Chicago-based manufacturing facility expansion to meet the region’s CDMO needs

18-Apr-2019 By Maggie Lynch

Completion of early-stage development site expansion at the Illinois Science and Technology Park supplies Chicago-based drug companies with refrigeration services for complex APIs.

Gilead doubles down on NASH with two deals in one week

16-Apr-2019 By Ben Hargreaves

Gilead arranges partnerships with insitro and Novo Nordisk to develop new options for patients with NASH.

Enesi and Oxford University look to create first effective plague vaccine

16-Apr-2019 By Vassia Barba

Enesi Pharma and OVG sign a collaborative agreement, hoping to combine a promising ingredient and an innovative delivery method to produce a plague vaccine.

Global API market set to grow to $268bn by 2025

12-Apr-2019 By Ben Hargreaves

The global API market will achieve a CAGR of 6.8% running up to 2026, taking the total value to $268bn, a report suggests.

LEO partners to reduce multi-hour dermatology treatments to seconds

11-Apr-2019 By Vassia Barba

LEO and Elektrofi begin development of injectable dermatological drugs to replace infusions, reducing the amount of time required for treatment.

GSK gets first approval for two-drug HIV treatment

09-Apr-2019 By Ben Hargreaves

GSK’s Dovato is approved by the US FDA for the treatment of individuals with HIV with no previous antiretroviral therapy, in a first for a two-drug, fixed-dose, complete regimen.

UPDATED

GSK and AZ partner with CPI for continuous manufacturing facility

08-Apr-2019 By Ben Hargreaves

UK pharma giants, GSK and AstraZeneca, collaborate with CPI to build a continuous wet granulation manufacturing facility for oral solid dosage drugs.

Antibióticos do Brasil expands Sao Paolo site by 25%

02-Apr-2019 By Ben Hargreaves

The Brazil-headquartered antibiotics company announces that it has invested in two new buildings, a few years after running into regulatory trouble due to non-compliance with cGMP.

How to tackle a sticky issue

27-Mar-2019 By Ben Hargreaves

Sticking is one of the most common issues that is faced in the manufacture of tablets, and may become a more pressing issue once continuous manufacturing is broadly adopted, suggests I Holland’s R&D manager.

Product loss mitigation through drying technology

26-Mar-2019 By Maggie Lynch

Small molecule manufacturing can result in product loss, as the materials manufactured come into contact with internal surfaces thereby impacting drying and creating disruptions in efficency and cost-effectivness.

Digoxin API supply secured through acquisition

26-Mar-2019 By Maggie Lynch

C2 Pharma acquires digoxin API product portfolio from Noblius to secure supply of the ingredient, after disruption of the supply of the API for a number of years.

Repackaged sartan tablets also face recalls

25-Mar-2019 By Maggie Lynch

Sartan recalls continue as Legacy Pharmaceutical Packaging recalls 40 lots of losartan tablets at the consumer level.

DEA license offers Cure hemp-based CBD manufacturing

21-Mar-2019 By Maggie Lynch

Cure Pharma expands its DEA license to include authorization to manufacture both cannabis plant extracts and CBD within the scope of its patent portfolio.

Expansion of Cambrex’s Milan site makes room for APIs

21-Mar-2019 By Maggie Lynch

Cambrex completes expansion of its R&D laboratory at its Milan site and adds a 12,000-liter reactor to its manufacturing facility during a $3m investment.

Issues of quality in pharmerging countries ‘more spoken about than real’

20-Mar-2019 By Ben Hargreaves

There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.

Mylan recalls sterile injection after particulate matter identified

19-Mar-2019 By Maggie Lynch

Mylan recalls two lots of levoleucovorin injection, after the presence of particulate matter with potentially severe health consequences was found.

Noramco to manufacture CBD to be delivered via the eye

14-Mar-2019 By Ben Hargreaves

Noramco partners with Nemus to produce an analogue of cannabidiol that possesses greater bioavailability, that could be used to treat diseases of the retina.

FDA approves valsartan generic as shortages develop

13-Mar-2019 By Ben Hargreaves

US FDA announces that a new generic for valsartan will reach the market, after prioritising the review of the product to alleviate shortages resulting from recalled products.

Addiction specialist expresses concern after FDA approves esketamine

07-Mar-2019 By Maggie Lynch

US FDA approves esketamine nasal spray for treatment-resistant depression, addiction specialist cautions against its use.

Pfizer licenses immune tolerance therapy for type 1 diabetes

07-Mar-2019 By Maggie Lynch

Pfizer exercises option from a previous agreement with AnTolRx to license immune tolerance therapy for type 1 diabetes.

Genentech taps Halozyme’s tech in Herceptin Hylecta

05-Mar-2019 By Maggie Lynch

Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.

Aurobindo facility receives Form 483 over procedural issues

05-Mar-2019 By Maggie Lynch

US FDA issues Form 483 to Aurobindo’s drug product manufacturing plant after it failed to follow sterile procedures.

Sartan issues continue as Macleods and Camber issue recalls

04-Mar-2019 By Maggie Lynch

Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.

FDA review gives Virpax go-ahead for pain relief candidates

26-Feb-2019 By Ben Hargreaves

A pre-IND review by the US FDA has allowed Virpax to continue with NDAs for DSF100 and LBL100, two pain relief products with specialised drug delivery formulations.

Drug delivery manufacturing evolves to keep up with intricate therapies

26-Feb-2019 By Maggie Lynch

A drug is only as effective as its delivery system, and the advent of new molecules and new innovations have to be matched by enhanced delivery and containment methods, suggests West Pharma exec.

Sanofi manufactures radiotherapy nanoparticles

26-Feb-2019 By Maggie Lynch

Sanofi agrees to produce French start-ups’ nanoparticle drug candidate indicated for the maximization of radiotherapy at its French site.

Novartis exercises option for RNA-targeting drug candidate

25-Feb-2019 By Maggie Lynch

Novartis exercises its option to license Ionis’ RNA-targeting cardiovascular drug, adding to its cardiovascular treatment portfolio, as Entresto reaches the three-year mark on its patent.

FDA’s draft guidance clears path for generic competition

19-Feb-2019 By Maggie Lynch

US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.

Lonza utilizes global network for CBD-based drug manufacture

18-Feb-2019 By Maggie Lynch

Lonza and Emerald Health enter an agreement for the large-scale manufacturing of a synthetic derivative of CBD and its oral drug product for the treatment of MS and other CNS diseases.

‘Simply unacceptable’: FDA warns against illegitimate opioids

18-Feb-2019 By Maggie Lynch

The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.

POLL

FDA seeks transparent relationship on manufacturing standards

15-Feb-2019 By Ben Hargreaves

US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.

Esketamine nasal spray for ‘debilitating mental illness’ recommended for approval

14-Feb-2019 By Maggie Lynch

US FDA Psychopharmacologic Drug Advisory Committee recommends Spravato, an intranasal form of esketamine, for approval based on its favorable benefit-risk profile.

Dr. Reddy’s facility struck by another Form 483

12-Feb-2019 By Ben Hargreaves

Dr. Reddy’s Bachupally manufacturing plant has received a second Form 483 from the US FDA in the past two years.

Dutch university funded to manufacture own version of €170k per year med

11-Feb-2019 By Ben Hargreaves

Amsterdam UMC given €5m to produce an affordable version of Leadiant’s CDCA, after price increases meant the drug was no longer covered by insurance.

Quality standards at the heart of generic development

08-Feb-2019 By Maggie Lynch

Developing generics that receive approval is more efficient when quality and production standards exist, explains USP CEO.

Lonza collaborates on commercial supply manufacturing for anti-coagulation antidote

05-Feb-2019 By Maggie Lynch

Portola and Lonza will collaborate on commercial supply the API for the former’s anti-coagulation antidote at Lonza’s facilities.

US FDA to publish additional guidance to ‘genericize’ complex drugs

05-Feb-2019 By Maggie Lynch

As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.

UPDATE

Europe to ban sartan medicines with any level of contamination

04-Feb-2019 By Ben Hargreaves

The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.

Next step in personalized medicine enabled by 3D printing

01-Feb-2019 By Maggie Lynch

As 3D printing technology continues to develop, it is becoming more disruptive to the pharmaceutical manufacturing industry as its value in drug delivery becomes apparent, according to IDTechEx.

Lupin hit with more regulatory challenges

31-Jan-2019 By Maggie Lynch

Lupin’s facility was given six observations after the FDA closed its inspection earlier this month.

Cannabinoid research: ‘Pharma on the sidelines with binoculars, not with a blind eye’

30-Jan-2019 By Ben Hargreaves

The approval of the farm bill has intensified interest in CBD but Nexien BioPharma CEO warns pharma-grade products are needed for patients with serious conditions.

Novo Nordisk selects ‘local presence’ for Asia-Pacific distribution

21-Jan-2019 By Maggie Lynch

Novo Nordisk Pharmatech selected DKSH to distribute its pharmaceutical grade compounds to the company’s growing customer base in the Asia-Pacific region.

EMA approvals up, rejections down in 2018

11-Jan-2019 By Ben Hargreaves

The EMA has provided its 2018 overview, which highlighted 84 positive opinions provided and five negative opinions.

Pfizer closes ‘not viable’ plants in India

10-Jan-2019 By Maggie Lynch

Pfizer has announced the closing of two of its India-based plants after product demand declines.

GeoVax and Enesi to develop next-gen thermostable, needle-free vaccines

08-Jan-2019 By Ben Hargreaves

The two companies will combine technologies to create solid-dose, needle-free vaccines for a number of infectious diseases and emergent threat pathogens.

Contaminated losartan sees 3.2m tablets recalled in Taiwan

03-Jan-2019 By Ben Hargreaves

Taiwan’s Food and Drug Administration announced that Siu Guan will instigate a recall of 11 batches of blood pressure tablets.

India requires 75% local content in pharmaceuticals

02-Jan-2019 By Ben Hargreaves

The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.

Mallinckrodt plans spin-off biz for generics, APIs, and Amitiza

17-Dec-2018 By Flora Southey

Under the Mallinckrodt name, its specialty generics business will be spun-off to shareholders and listed on the New York Stock Exchange.

US farm bill a boon for pharma?

13-Dec-2018 By Flora Southey

If approved by President Trump, the five-year farm bill – which removes hemp from the federal controlled substance list – could help advance cannabinoid R&D, says Nexien Biopharma.