Delivery technologies

Directly compressible starch by Colorcon promises simpler tableting

21-May-2019 By Vassia Barba

Colorcon expands its portfolio of direct compression solutions, with the launch of StarTab, a tableting excipient based on starch.

Hovione Technology acquires rights to pulmonary inhaler

23-Apr-2019 By Ben Hargreaves

Hovione Technology reaches an agreement to acquire the global rights to a reusable, cost-efficient, dry-powder inhaler.

Aquestive’s oral film ALS medication approved by FDA

23-Apr-2019 By Maggie Lynch

US FDA approves Aquestive’s oral film medication for the treatment of ALS using its PharmFilm technology.

NEWS IN BRIEF

MS Pharma acquires Genepharm, expands chronic disease portfolio

23-Apr-2019 By Vassia Barba

Jordan-based MS Pharma announces the acquisition of the Greek generic manufacturer Genepharm, aiming to add cardiovascular, CNS and oncology products to its portfolio.

Colorcon expands coating portfolio with DuPont’s Aquacoat

22-Apr-2019 By Vassia Barba

Colorcon adds DuPont’s Aquacoat technology, held in CR Alliance’s portfolio, whilst planning to transition existing customers over to the company.

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.

Boehringer acquires ICD to ease biologic delivery

15-Apr-2019 By Maggie Lynch

Boehringer acquires rights to ICD Therapeutics and its biologics-delivery platform for the development of oncology and immune oncology compounds.

Pfizer’s Vizimpro given go ahead be European Comission

11-Apr-2019 By Maggie Lynch

The European Commission approves Pfizer’s Vizimpro monotherapy for the first-line treatment of non-small cell lung cancer, as the market is projected to grow to $26.8bn by 2025.

Applications of nanotech may provide bioavailability

26-Mar-2019 By Maggie Lynch

Nanotechnology may be able to increase bioavailability in low-solubility drugs and improve a drug’s chance of success, according to Ascendia CEO.

FDA approves first drug specifically for postpartum depression

25-Mar-2019 By Maggie Lynch

The treatment, developed by Sage Therapeutics, is administered via continuous IV infusion for 60 hours.

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.

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.

RNAi therapies through ‘tough patch and here to stay’

27-Feb-2019 By Ben Hargreaves

Phio is working to apply RNAi technology in immuno-oncology, and believes that breakthroughs could be seen in the near future.

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.

Round-up: Innovations and developments in drug delivery

26-Feb-2019 By Maggie Lynch

Innovations in drug delivery have hit the market running and as complex drugs breaking onto the market while delivery systems and technologies follow.

Global injectable drug delivery market to double by 2025 to $932m

26-Feb-2019 By Ben Hargreaves

A report suggests that the global injectable drug delivery market will expand at a CAGR of 11.2% between 2019 and 2025.

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.

Haselmeier manufacture disposable injection device after receiving allowance

25-Feb-2019 By Maggie Lynch

Haselmeier to provide assembly, labeling, and packaging services for its drug-device combination products following recent permission given to Germany-site.

Mylan’s generic to cost 70% less then Advair

12-Feb-2019 By Maggie Lynch

Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.

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.

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.

First generic to Advair is approved after long wait

31-Jan-2019 By Ben Hargreaves

GSK’s luck at maintaining sales on its off-patent Advair product has run out, with Mylan’s generic version receiving approval from the US FDA.

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.

Purdue pivots towards non-opioid painkillers in $275m deal

29-Jan-2019 By Ben Hargreaves

Purdue announced that it has entered into a partnership deal with Alivio to develop a non-opioid painkiller for the treatment of cystitis and bladder pain syndrome.

MedPharm meets increasing demand with facility expansion

24-Jan-2019 By Maggie Lynch

MedPharm expands its US Center of Excellence in Durham, North Carolina, in response to increasing demand for its topical and transdermal formulation development, and performance testing services.

Complex transdermal generic drug receives approval, enters market

22-Jan-2019 By Maggie Lynch

Amneal received approval of a generic of the Exelon patch, a complex generic transdermal drug delivery system, and plans to commercialize the product.

Sandoz launches EpiPen rival with 16.5% price reduction

21-Jan-2019 By Ben Hargreaves

Sandoz becomes the latest company to launch a generic version of Mylan’s EpiPen in the US and has undercut its rivals on pricing.

‘Response rate to top selling drugs is 10%’, says Scipher CEO

18-Jan-2019 By Maggie Lynch

Scipher announced positive outcomes of its retrospective trial for its test Prism used to predict clinical utility, with data predicting it could double patients’ response rate to major therapies.

Lilly cuts 250 jobs and invests €100m at French site

15-Jan-2019 By Ben Hargreaves

Lilly France announced 250 positions will be cut from its Fegersheim site but will also invest €100m to update facilities over the coming years.

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.

US FDA on-board with first inhaled treatment for Parkinson’s

08-Jan-2019 By Maggie Lynch

FDA approved the first and only inhaled treatment for patients for the ‘most serious’ issue Parkinson’s patients face: OFF episodes.

Almac expands neo-antigen peptide manufacturing

02-Jan-2019 By Maggie Lynch

Almac announced it has increased its supply of neo-antigen peptides for individualized cancer treatments with the addition of another stream of GMP manufacturing.

UK grants CRDO £1m to speed up production of complex medicines

17-Dec-2018 By Maggie Lynch

The UK Government has granted Arcinova funds to develop its digital manufacturing platform to produce patient-specific medicine at an accelerated rate.

Sandoz’ EpiPen rival will launch in Q1, with lower price tag

10-Dec-2018 By Maggie Lynch

Sandoz will launch its epinephrine generic in early 2019 at a lower price point than rival generics on the market.

Simpler drug delivery through capsule-based inhalation

10-Dec-2018 By Ben Hargreaves

Delivery by inhalation could be an easier way to deliver therapies in areas such as oncology, suggested ACG’s development manager.

Shouldering the responsibility: Male birth control absorbed through skin

05-Dec-2018 By Maggie Lynch

A clinical trial has begun to test the safety and efficacy of male birth control in a drug delivered through application on the arms and shoulders.

‘Colour is crucial’: Capsule choice more than a brand statement

03-Dec-2018 By Ben Hargreaves

The colour of a capsule can play an important role in the safety of a product and provide consumers with intuitive information for dosage, according to Nicolas Madit of Lonza.

Q&A

Biologics delivery tech could accelerate wound healing by 80%, says Ilya Pharma

03-Dec-2018 By Flora Southey

The Swedish biotech’s lead candidate, ILP-100, is designed to continuously deliver biological drugs to the wound surface for approximately one hour.

WuXi STA aims to ‘add one API plant every year’, says VP

03-Dec-2018 By Ben Hargreaves

STA Pharmaceutical sees building out its own manufacturing infrastructure as a stronger growth plan compared to pursuing acquisitions.

First generic EpiPen enters the market at half the cost

29-Nov-2018 By Maggie Lynch

Teva’s EpiPen generic will reach market at a cost of $300 per pack, which matches the price of Mylan’s own generic version.

Q&A

An easy pill to swallow: Colorcon tech targets the old, young, and pill-fatigued

26-Nov-2018 By Flora Southey

Swallowability is a recognised and growing patient problem, according to Colorcon’s general manager of film coatings, Kelly Boyer.

Q&A: mRNA’s place in vaccine manufacturing with CureVac

19-Nov-2018 By Maggie Lynch

Messenger RNA is demonstrating success in vaccine manufacturing and CureVac is giving it the place to do so with the development of a prophylactic vaccine with mRNA at its core.

AAPS PharmSci360

‘The rules of the game’: Applying first principles of engineering to manufacturing

16-Nov-2018 By Maggie Lynch

Bernard McGarvey, formerly of Eli Lilly, spoke with us about first principles of engineering in pharma, following his keynote ‘Engineering First Principles Applications to Pharmaceutical Manufacturing.'

US FDA approves oral film formulation for treatment of rare seizure syndrome

12-Nov-2018 By Maggie Lynch

FDA approves first and only oral film formulation drug for seizures associated with Lennox-Gastaut syndrome.

NEWS IN BRIEF

Hovione expands production capacity of oral dosage forms

12-Nov-2018 By Ben Hargreaves

The Portuguese CDMO has announced plans to improve production capacity by bringing in commercial scale equipment for blending, tabletting and coating.

AAPS PharmSci 360: Quotes that carry

09-Nov-2018 By Maggie Lynch

This week in-PharmaTechnologist attended AAPS PharmSci360 in Washington, D.C. where discussions and thought-provoking ideas bounced across sessions – here, we highlight some of the most significant.

US FDA hits Akorn with second Form 483 this year

08-Nov-2018 By Ben Hargreaves

Akorn’s Somerset facility becomes it second to require remediation action, following the issuance of a US Form 483.

Gene therapy de-coded: Utilizing mRNA ‘programming language’ for therapy production

02-Nov-2018 By Maggie Lynch

A study published by graduate students at MIT showed that a synthetic mRNA-based ‘programming language’ can control protein expression in gene therapy.