Delivery formulations

FDA approves BioMarin drug to treat dwarfism in children

22-Nov-2021 By Jenni Spinner

The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.

AstraZeneca: lupus drug candidate shows promise in Phase III trial

16-Nov-2021 By Jenni Spinner

According to the pharma firm, Saphnelo (anifrolumab) combined with standard therapy resulted in reduction of systemic lupus erythematosus disease activity.

Gene-edited cell replacement therapy for diabetes set to enter the clinic

16-Nov-2021 By Rachel Arthur

CRISPR Therapeutics and ViaCyte, Inc. have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D)....

Pfizer inks COVID-19 treatment licensing agreement with MPP

16-Nov-2021 By Jenni Spinner

The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.

TFF completes dosing in Phase Ib clinical study for asthma drug

15-Nov-2021 By Jenni Spinner

The firm is investigating viability of voriconazole inhalation powder, intended to treat and prevent invasive pulmonary aspergillosis in asthma patients.

Biohaven wraps patient enrollment for ALS clinical trial arm

15-Nov-2021 By Jenni Spinner

The pharma company has completed enrollment of amyotrophic lateral sclerosis patients in its study investigating drugs like verdiperstat, an oral treatment.

Baxter investing $100m to bolster German sterile fill/finish facility

11-Nov-2021 By Jenni Spinner

The infusion of funds in the Halle/Westfalen, Germany manufacturing complex is intended to help meet growing global demand for injectable pharmaceuticals.

CPHI WORLDWIDE

Carrier solution addresses challenging liquid APIs: W.R. Grace

03-Nov-2021 By Jenni Spinner

The CPhI Worldwide exhibitor will show Syloid XDP, a silica carrier designed to convert liquid, waxy, or oily active ingredients into free-flowing powders.

CPhI Worldwide

Gerresheimer develops delivery device for drugs with higher viscosity

03-Nov-2021 By Jane Byrne

CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drug delivery systems for newly developed biologics along with medical and diagnostic products.

CPHI WORLDWIDE

Hybrid CPhI Worldwide 2021 a ‘celebration’ of pharma industry

02-Nov-2021 By Jenni Spinner

The global pharmaceutical industry event is returning to the real world November 9-11 this year, with online content for professionals opting not to travel.

Gilead, Merck launch Phase II trial evaluating oral regimen for HIV-1 treatment

01-Nov-2021 By Jenni Spinner

The trial will evaluate a weekly regimen of islatravir and lnecapavir in HIV patients who are virologically suppressed while on antiretroviral therapies.

Potential COVID-19 treatment to wrap up Phase III trial

26-Oct-2021 By Jenni Spinner

Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.

Digital revolution transforming drug development: West Pharma

18-Oct-2021 By Jenni Spinner

A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.

AAPS PharmSci 360

PharmSci 360 invites industry pros to ‘rethink and evolve’

14-Oct-2021 By Jenni Spinner

The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.

CytoReason, Summit tap into AI on Japanese drug development effort

12-Oct-2021 By Jenni Spinner

The AI technology firm and pharma services company are joining to help one of the country’s leading pharmaceutical firms develop a promising drug candidate.

Data advances, environmental factors driving device innovation: Pharmapack

11-Oct-2021 By Jenni Spinner

Organizers of the drug delivery and packaging event have shared an industry report that reveals what is likely to push innovation forward in the future.

Generics price fixing charges land pharma firms $447.2m penalty

05-Oct-2021 By Jenni Spinner

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations

Merck: COVID-19 oral antiviral drug reduces risk of death

01-Oct-2021 By Jenni Spinner

The pharma firm reports molnupiravir was shown to cut risk of hospitalization or death by 50% compared to placebos in a positive interim Phase III analysis.

Merck to acquire Acceleron Pharma, strengthening cardiovascular pipeline

30-Sep-2021 By Rachel Arthur

Merck (MSD outside the US and Canada) will acquire Acceleron in a deal worth around $11.5bn.

Update on FDA COVID approvals, actions, and advice

24-Sep-2021 By Jenni Spinner

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

FDA approves IND application for peanut allergy drug candidate

16-Sep-2021 By Jenni Spinner

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

GSK rhinosinusitis drug receives thumbs up from the FDA

09-Sep-2021 By Jenni Spinner

Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.

Inflammasome develops combo HIV/birth control implant

23-Aug-2021 By Jenni Spinner

Thanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.

SPI launches UltraBurst excipient designed for ODT formulation

18-Aug-2021 By Jenni Spinner

The pjarmaceutical excipient, intended for use in the formulation of flash orally dissolving tablets, is designed to disintegrate in less than 10 seconds.

Orally disintegrating tablets offer range of patient benefits: Roquette

18-Aug-2021 By Jenni Spinner

A leader from the excipients firm discusses how ODTs appeal to seniors and patients on the go, and the formulation-related challenges with such tablets.

Secure pharma supply chain requires connections, information

18-Aug-2021 By Jenni Spinner

A representative from Clarivate explains how supply chain vulnerabilities can hurt stakeholders, including patients—and how one solution can close the gap.

Philip Morris acquires another inhaled-drug pharma firm

10-Aug-2021 By Jenni Spinner

The US-based company continues its move away from smoking products with the purchase of drug developer OtiTopic, as part of its Beyond Nicotine initiative.

cphi north america 2021

Pharma event welcomes industry professionals ‘keen to meet’

04-Aug-2021 By Jenni Spinner

Producers of CPhI North America 2021 offer a glimpse at programming, including sessions on COVID-19 challenges, supply chain issues, and more key topics.

mRNA and beyond: Opportunities for US biologics

03-Aug-2021 By Staff reporter

The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceutical manufacturing looking forward, with pandemic investments helping turbocharge the sector.

Spotlight on single-use systems: 3 trends driving demand

03-Aug-2021 By Staff reporter

Adoption of single-use technologies has grown exponentially over the last decade: but what will drive the tech forward in the coming years?

Psychedelics research institute launches in Australia

03-Aug-2021 By Jenni Spinner

The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development.

BMS, BridgeBio partner to study drug combo for lung cancer

27-Jul-2021 By Jenni Spinner

The two pharma firms will partner to study the efficacy of Opdivo, paired with a SHP2 inhibitor, to treat non-small cell lung cancer with KRAS mutations.

People on the Move: July 2021

08-Jul-2021 By Jenni Spinner

This month’s news on hires, promotions, acquisitions, and expansions includes items about Javara, Elligo, Lonza, Yourway, Medable, and other notable firms.

Hot-melt extrusion can improve bioavailability: Avomeen

14-Jun-2021 By Jenni Spinner

With bioavailability challenges a frequent frustration for drug developers, one research outfit suggests a technique that could reduce the headaches.

Novo Nordisk weight-management drug lands FDA approval

07-Jun-2021 By Jenni Spinner

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

Azzur opens new on-demand cleanroom facility in California

03-Jun-2021 By Jenni Spinner

The company’s Azzur Cleanrooms on Demand division has established another facility in Vista, a city in the San Diego Area, for life-sciences operations.

People on the Move: June 2021

02-Jun-2021 By Jenni Spinner

This month’s roundup of hires, acquisitions, anniversaries, and other announcements includes news from Premier Research, Cytel, ACG, and other companies.

Special Edition: BIO DIGITAL 2021

‘HIV remains a pandemic of inequalities’: The fight against HIV/AIDS, 40 years on

02-Jun-2021 By Rachel Arthur

June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital – featuring Dr. Anthony Fauci, Director of NIAID at the NIH – will focus on four decades of innovation as well as the critical...

Newly launched ‘skunkworks’ firm seeks to elevate drug development

27-May-2021 By Jenni Spinner

Created by an industry veteran with more than 20 years’ experience, Protodigm aims to offer innovation and expertise to pharmaceutical industry clients.

Sanofi and GSK take COVID-19 vaccine into Phase 3 study

27-May-2021 By Rachel Arthur

Sanofi and GSK have started the Phase 3 study for their COVID-19 vaccine candidate: eying up potential regulatory authorization in Q4, 2021.

Online HPAPI Summit takes on key pharma ingredients topics

19-May-2021 By Jenni Spinner

The virtual event (scheduled June 22-24) will feature presentations from Bayer, Merck, GSK, Novartis, Takeda, FDA, WHO, and other notable organizations.

Cancer drug developer aims to elevate treatment

13-May-2021 By Jenni Spinner

A leader from clinical-stage pharma firm NuCana shares promising results for its ProTides therapies and hopes the drugs can elevate outcomes for patients.

Could synthetic biology solutions fix supply chain challenges?

11-May-2021 By Jenni Spinner

An expert from synthetic biology tech firm Antheia offers ways to rethink current sourcing and manufacturing strategies to tackle current and future woes.

Lonza leader outlines small-molecule trends for 2021 and beyond

06-May-2021 By Jenni Spinner

The head of small-molecule business for the pharma solutions specialist talks about obstacles, and how companies can work to clear them for future success.

Nanoform, Aprecia partner on 3D-printed nanomedicines

27-Apr-2021 By Jenni Spinner

The two companies plan to collaboratively explore ways to combine 3D printing and nanotechnology, in order to create nanoparticle-enabled dosage forms.

Pfizer pours $25m into Vedanta's Phase II IBD study

19-Jan-2021 By Jenni Spinner

The pharma giant has invested in the clinical trial exploring the viability of Vedanta Biosciences’ VE202 inflammatory bowel disease treatment candidate.

Grifols to launch trial for potential COVID-19 therapy

19-Jan-2021 By Jenni Spinner

The subcutaneously administered immunoglobulin, if successful, would provide rapid immunity against the virus behind the deadly global pandemic.

LA customs agents seize $19m in counterfeit Viagra pills

13-Jan-2021 By Jenni Spinner

Authorities discovered the fake Pfizer erectile-dysfunction tablets in one of three cargo containers full of fraudulent goods, recently arrived from China.

AI-driven drug discovery collaboration to tackle neurological diseases

12-Jan-2021 By Jenni Spinner

Sosei Heptares and PharmEnable will harness artificial intelligence-enabled technology and advanced chemistry to explore neurological disease solutions.

Repurposing existing drugs accelerates discovery: XenoTech

12-Jan-2021 By Jenni Spinner

Exploring alternative uses for drugs tapped for other indications, can save considerable time and money in discovery, according to an expert from the CRO.